Dr. Thomas Borody on Fecal Transplant and Cure for Crohn's?

Recently an article came out about Dr. Thomas Borody claiming that a fecal transplant might be used for a whole host of things from multiple sclerosis, to Crohn's, to Parkinson's disease. In the article nurse Suzanne Heskett had Crohn's and seems like she had a bad flare up in 2001. She was going to the bathroom 18 times a day and thought she would have to get part of her colon removed. In trying to help her dire health situation she went to Dr. Thomas Borody (who even I will admit is a gastro star doctor in Australia and has done tremendous research in gastroenterology in general).

Suzanne had a nasal tube and three different donors donate their "stuff" which took about 5 hours and she felt better right after and several months later her condition improved. What is interesting is that 11 months after having a colonoscopy and Dr. Borody didn't even recognize she had Crohn's. Borody first did a fecal transplant for Crohn's in 1988 according to this journal article.

Borody goes on to say that he has done a fecal transplant for someone with a young person with rheumatoid arthritis and it went away after the transplant. He also claims that he has "cured" dozens of people with colitis and Crohn's. Dr. Borody also claims that three Parkinson's patients was helped by fecal transplants. Fecal transplant even has the potential to help patients with Alzheimer's, autism, obesity, rheumatoid arthritis, acne, insomnia, major depression, autism, and even diabetes. 

I am a little skeptical of the claims that fecal transplants will "cure" Crohn's, however I don't think a fecal transplant would hurt Crohn's patients. Speaking as someone who actually had a fecal transplant in 2013 I did feel a little better after the transplant, however still had a flare up (which could have been caused by the c diff I had). However, I feel pretty great now and some days don't even realize I have Crohn's. All the research I have seen tends to show fecal transplant work better for ulcerative colitis. 

If you don't live in Australia Dr. Thomas Borody will charge $10,000-$15,000 and you can be expected to stay between 2 and 10 weeks and have to have a doctor that will resume care after the procedure. The first step however is to have an initial interview which would cost $150. However, Borody has been doing fecal transplants since the 1980's and as I wrote here does 5-6 per week and I estimate by now has done close to 2,000 fecal transplants.

The application of fecal transplant for multiple illnesses sounds exciting. Perhaps the reality will be it won't be apply to as many things as possible but could have an impact on people with Crohns, ulcerative colitis, and other major diseases. Hopefully, with time we will learn even more about fecal transplants and how they can help hundreds of thousands if not millions of people suffer less and enjoy life more. 

Weekend Links: Drugs Cut Surgery by 60%, Texting, SCD Diet Study, Marijuana Helps Crohn's, JAK1 Study for Crohn's, Golimumab, Fecal Transplant Helps UC and IBS

(Note: I started this post on Saturday however wasn't able to finish it as I saw some more stories to add).

Drugs Cut Need for Surgery By 60% 

     You could say if there is any time to get Crohn's if you had to get it. So in a study that looked at 5,000 patients and looked at the effect of the thiopurine drugs. Azathioprine  for more than 12 months had a 60% reduction within the first 5 years of diagnosis. Thiopurines have been around since the 1970's.  

Texting Helping Children with Crohn's 
      The medical expenses for treating IBD are quite high. Estimates place of IBD is roughly $1.8 billion according to the CCFA. So one way to bring down the costs may be using doctors in order to get patients and doctors to communicate with one another. A clinical trial is taking place at Cincinnati Children's Hospital were an application which uses information from the user and sends it back to the doctor. Patients can respond if they are taking their daily medications and how many times the patient felt sick. The app can track the behavior and get an early idea of when a flare up might occur. The CCFA website has an app called GI Buddy that people can download and track nearly everything related to IBD (bowel movements, what you eat, how you feel, etc). Technology is a no brainer is reducing costs related to not only Crohn's but other chronic illnesses. If you had data on 1,000 different Crohn's patients and ran some analysis on it you could find patterns (what foods help with Crohn's, what foods are likely to cause a flare, what medication works, etc). If patients were able to have their information sent to doctors and doctors could data mine the data to see what patients needed to be responded to first it would make things much more efficient (for both the doctor and patient).
    

Small Study on SCD Diet 
     So in a very small and uncontrolled trial Dr. Ece Mutlu at Rush University looked at 20 patients who adhered to the specific carbohydrate diet (SCD). There is plenty of controversy about this diet. The Crohn's and Colitis Foundation (CCFA) doesn't believe that diet helps. However, if you read internet stories you can find dozens of people who have seemed it helped. This study just looked at the intestinal bacteria. Mutlu claims that some of his own IBD patients have "drastically improved" with mucosal healing and were able to discontinue their immunosuppressants for several years.

Marijuana Treats Crohn's (How Many More Studies Do We Need)
     In a recent study published in the journal Pharmacology showed that cannabis has been shown to help people with cannabis. I have not seen anything published that shows marijuana has a negative impact on Crohn's. This study showed that 70% of patients improved after treatment (this first study was done in 2011). In a follow up study found that 90% of patients had a decrease in their symptoms while 45% of patients had a remission of their Crohn's. Clearly, cannabis should be something that is studied more to see if it can help people with Crohn's. With Colorado allowing people to possess cannabis without any legal trouble it seems perhaps more people will be able to experiment and see if it helps them.

Galapagos Phase 2 Trial For JAK1 Inhibitor for Crohn's 
According to this press release to conduct a phase 2 trial on a JAK1 inhibitor. In the past JAK1 inhibitor as pointed out by Dr. William Sandborn here. Dr. Edward Loftus had a concern about the lipid effects as the drug did increase LDL (bad cholesterol) however Loftus said it wouldn't be a deal breaker. The trial will enroll 180 patients (over 49 different clinic centers around the world) for a 20 week trial.

Golimumab Maintains Clinical Response in Patients With Ulcerative Colitis
     In this phase 3 trial patients were given either 50 mg or 100 mg (subcutaneous injection). There were 464 patients that were enrolled in the trial. Roughly 47% of patients who took the 50 mg treatment were in remission as opposed to the nearly 50% of patients that were in remission in the 100 mg group. 3 patients did die (they were all taking the 100 mg dosage too). Also remember that 3 patients out of 464 is a little more than 1/2 of 1%.

Fecal Transplant Shows More Promise for Ulcerative Colitis and IBS
      So fecal transplant which by the way I believe saved my life is being studied for digestive disease such as Crohn's and ulcerative colitis. All the data I have suggests that fecal transplant would benefit ulcerative colitis patients more than Crohn's patients. Dr. Brandt who has been doing fecal transplants for a long time reported that 63% of his patients (16 patients had IBD-with 14 having UC and 2 having Crohn's) had a lower frequency of flares after they had fecal transplants. The diarrhea also decreased by 56% (8.2 bowel movements to 3.6 bowel movements) after the fecal transplant. Symptoms resolved in 29% of patients and decreased by 43% of patients (21% of patients saw no change). Which means almost 80% of patients saw some benefit to a fecal transplant. Dr. Brandt also looked at fecal transplant for IBS patients and found that 73% of patients had a complete or partial resolution of their symptoms.

Weekend Links: FDA Worries Theoretical Side Effect from Vedolizumab, Fecal Transplant Houston, Women Goes On Macrobiotic For Crohn's, Colon Test Detects 85% of Cases, NOTES Surgery for Gastrointestinal

FDA Worries About Theoretical Risk for Vedolizumab

So the great geniuses at the FDA have called into question the drug Entyvio (vedolizumab) for concerns that it could theoretically could happen. The FDA in their wisdom wrote a 177 report that can be found here. When I have some more time I will write a full blog post on this. What the FDA is worried about is that since vedolizumab operates similar to a drug named Tysabri (natalizumab). One potential side effect is PML which is a fatal brain infection that can be acquired from taking Tysabri. However, the risk of getting PML is estimated to be 1 in 1000. So even though 31 confirmed cases of PML have been reported you have to look at how many people overall are taking it. What is interesting is that now there is a test JC Virus Test to see if there is a presence of the virus to see if it can lead to PML. The JC Virus test is required in order before one takes Tysabri. Even having the JC Virus doesn't mean one will get PML it just means that one has an increased risk of getting it. With costs are benefits. Vedolizumab seems to be most beneficial for patients who have ulcerative colitis as in the clinical trial 47% of patients who took it after six weeks were in remission compared to the placebo of just 25.5% (result was statistically significant). 

The FDA said basically well since this drug vedolizumab is similar to Tysbari we should expect the same thing to happen. However, what is quite interesting is that even the FDA report states that "at this time no en cases [of PML] have be reported in patients taking vedolizumab. In the trial over 1400 patients received vedolizumab and not one patient actually contracted PML. The FDA is as usual over concerned about the potential side effect of a literal 1 in 1000 chance (the trial proves it is probably less considering no one actually got PML) when the condition of Crohn's or ulcerative colitis one could argue is much more dangerous.

Fecal Transplant Now Done In Houston

Here is a story out of Houston showing how a patient with c difficle got their life back after a fecal transplant. Dr. Herbert Dupont is leading the fecal transplant program in Houston. The procedure only takes 10 minutes and patients feel much better very soon. Dr. Dupont is currently doing a study to see if c difficle can help patients with Crohn's disease and ulcerative colitis. 

Women Goes On Macobiotic Diet for Crohn's: No Pain 

So I am always interested in seeing stories about diet and Crohn's disease. I think diet does play some role in Crohn's, however it is important to remember some patients can go decades without symptoms of Crohn's. So Ruth Twort has had Crohn's disease for 30 years (since 1983) she is now 49. She has changed her diet to just eat macrobiotic foods (she eats porridge, brown toast, and roast chicken). She substitutes agave syrup for sugar. She also eats Sushi 2-3 times per week. For Crohn's flare ups she will eat miso soup with soba noodles. She also never drinks whole milk. I think eating well in general is good for health. Being diagnosed with Crohn's has made me more health conscious in what I select as food. I really would like to see a study done of people before and after they try these diets (a colonoscopy at the beginning and one done 6 months to 1 year after the diet has been tried). 

Blood Test 85% Effective for Colon Cancer
So many people don't like having a scope inside of them (really a colonoscopy is a piece of cake the prep is the hardest part). About 50% of people avoid them because they don't want to deal with it which could mean many people have possible colon cancer or other gastro issues. A new blood test can now with 85% accuracy detect cases. I am sure as more people are studied (200 have been studied so far) the test will only become better and cheaper which can spare many people from having a colonoscopy which would free up gastro docs to see IBD patients and save insurance companies bundles of money.

NOTES (Natural Orifice Surgery) Being Used For Gastroenterologists: No Incision/Scar

I am always a fan of doing things better and more effective. NOTES (Natural Orifice Surgery) allows surgeons seems to offer advantages over conventional minimal surgery by avoiding incisions and as the name suggests goes through natural orifices in order to perform surgery. Some of the procedures that can be performed by NOTES are bariatric repairs, fistulas, and ulcers. Patients usually go home after 1-2 days with less pain and best of all no incision or scar. Currently, NOTES is relatively new and will take time before it becomes adopted by more surgeons. 

Weekend Links: IBD and Race, Surgery Rates IBD Falling!, Vitamin D & Crohn's, Paneth Cells, and Poop Pills

Risks of Inflammatory Bowel Disease Between Racial and Ethnic Groups
This article discusses the rate at which various types of ethnic groups get diagnosed with IBD. What I also learned is that it is estimated that 1.8 million adults have IBD (usually the estimate is around 1.0-1.1 million).  What is interesting is that Non-Hispanic Whites have the highest rate (70.2 people/100,000 people) while Hispanics have the lowest rate at (9.9 people per 100,000). However the article concluded that deaths and hospitalizations and deaths from IBD was higher in Non-Hispanic Blacks. So to summarize white individuals are more likely to get IBD, however African Americans are more likely to be hospitalized and die from it.

Changes in medical treatment and surgery rates in IBD (1979-2011)
Long term studies like this always interest me. This study found that the chances of requiring surgery (for Crohn's disease) over a 5 year period have decreased from 44.7% (if you got diagnosed between 1979-1986) to 19.6% (if you were diagnosed between 2003-2011). I was diagnosed in 2011 so the percentage might actually be lower since people didn't  use biologics until after 2008.  The requirement of surgery for UC also decreased from 11.7% (if diagnosed from 1979-1986) to 7.5% (if diagnosed between 2003-2011). I have seen other studies that show the cumulative risk of surgery increases over time. However, other factors like how severe the disease is, the age at which you are diagnosed, and the location of the disease can play a factor in when you need surgery and how often.

Stool Banks for Fecal Transplants: Crap Now Worth Something!
As someone who earlier this year had c difficle and then a fecal transplant at the Mayo Clinic I am always interested in fecal transplants. This story is interesting in that Dr. Lawrence Brandt believes that in the future there will be stool banks just like blood and sperm banks which makes sense consider the stool can be used to save people with c difficile. What would be interesting is people actually getting paid for their crap! What would even be more interesting is if certain stuff is more valuable in terms of a curing c difficile. Also if people knew they could get paid to donate their stuff they make have an incentive to take care of themselves and not do things that may exclude them from being a donor (taking an antibiotic, living a risky lifestyle, etc.). Fecal transplants are also being studied in other disease such as Parkinson's, obesity, and even IBD. It would be nice to study if certain fecal material is better than others in helping people with these horrible illnesses.

Too Much Vitamin D for Crohn's Patients?
This article on vitamin D is interesting because it often contradicts what I have heard saying that people with Crohn's usually have low levels of vitamin D. What is interesting is right before I was diagnosed with Crohn's my doctor told me to take a vitamin D supplement (which in all honesty does make me feel better when I take it. The research was done by Dr. Maria Abreu (she is with the University of Miami IBD department). In the study (which is in Gut magazine) showed that Crohn's patients 42% of patients have "inappropriately high" levels of vitamin D levels. The same was true for 7% of patients with UC. The theory is high vitamin D levels are most likely a manifestation of the underlying gut inflammation.

New clinical trial for antibiotic to help Crohn's (possible cure?) 
Dr. Saleh Naser out of UCF College of Medicine has spent 18 years studying mycobacterium avium subspecies paratuberculosis (MAP) in Crohn's disease. There is a debate in the scientific community as to what actually causes Crohn's disease. Dr. Naser is trying to enlist 240 patients in a clinical trials for basically what is an antibiotic therapy. There is also a test being developed to see what patients have MAP in their systems in order to determine who would benefit most from the new treatment. What is very promising is that Dr. Naser believes that patients with the treatment may instantly improvement and this could possibly believe a cure for Crohn's if MAP is truly the underlying cause.

Paneth Cells Role in Inflammation for Crohn's Disease
According to this article from Nature . This Science Daily article breaks the research down into plain English. What the research shows is that there may actually be subsets of Crohn's disease. What was learned is that Paneth cells' play a role in inflammation for inflammatory bowel disease. Hopefully, this will lead to more targeted therapies for Crohn's.

Poop Pills: Now Serving C Difficile Patients
Speaking of fecal transplant apparently Dr. Thomas Louie out of University of Calgary developed a "poop pill" to help people who suffered from c difficile. I know people in the media will say "poop pill" how gross and make fun of the name. However, there is nothing funny about c difficle (I know I have been through it and felt like I was partly dying). At any rate, 32 patients were treated with the pills and didn't have a recurrence of c difficile which is a 100% success rate. If fecal transplants could be done in pills instead of via colonoscopy it would be far cheaper, easier, and free up doctors to do procedures on people who might need them more (people who may have colon cancer). This pill came faster than I thought. I thought it would take many years to develop this but apparently it is here faster than we could have imagined.

Mid-Week Links Part II: Probotics Don't Help Crohn's, Fecal Transplant Cures 97% of C Diff, Pill Camera Approved For Crohn's

Probiotics Doesn't Help Flares For Crohn's
     This study showed that taking probiotics doesn't help Crohn's patients. 47% of the people who took probiotics had relapsed while 53% of the patients in the placebo group relapsed. Really there was no statistical difference between the two groups.

 Fecal Transplant at Mayo: 97% Effective in C Difficile
    This study out of the Arizona Mayo Clinic (they have branches all over the United States) showed that 97% of patients who received a fecal transplant got rid of their c difficile. A majority of patients noticed an improvement in 3 days. The study was only done on 31 patients however this is another data point showing fecal transplants are effective! Hopefully, we can see in the future if fecal transplants can help things like ulcerative colitis, Crohn's, Parkinson's disease, multiple sclerosis, autism, obesity, and maybe even depression.

Pill Camera Approved For Crohn's
     The FDA cleared the PillCamera SB 3 for Crohn's disease and anemia. I believe the SB stands for small bowel. What is interesting is that 75% of Crohn's patients have lesions in their small bowel. What is even more interesting is that after 3 months of using the camera 62% of patients changed treatment and 40% of patients changed medication. Basically you just take the pill camera with a glass of water and it takes pictures of your small bowel and sends them to your doctor (you wear a small belt and recorder). More than 2 million people have already taken the PillCamera which is interesting. The risks are pretty minor. The risk of retention is less than 3% for Crohn's patients.

Mid-Week Links: Heat and Crohn's Flares, $1.5 Million Crohn's Research, MicroBiome in Crohn's, and Implantable Device For Crohn's

Heat Waves and Crohn's Flares 
     This article from the August issue of The American Journal of Gastroenterology shows that a heat wave increased IBD flares by about 5%. This is interesting because I live in both a hot and humid state. What would be interesting is it there was a worldwide study looking at patients from various countries all over the world and looking to see if warmer temperatures in general caused flares. I know someone who is dating a guy who has Crohn's for a long period of time and his metric is every 4th of July he knows he will feel bad. Maybe there is some truth to this study.

Kenneth Rainin Foundation Awards $1.5 million For IBD Research
    The Kenneth Rainin Foundation which is a non-profit created by Kenneth Ranin who was an entrepreneur founded an instrument company and created a foundation to support the arts, sciences, and health research. The foundation actually established an IBD center at UCSF. Ranin has a daughter (Jennifer) that was diagnosed with ulcerative colitis (she also has a Ph.D). The $1.5 million will be used to invest in research that can help understand causes and cures for inflammatory bowel disease (IBD).

Distinct Microbiome in Crohn's Intestinal Mucosa
      Researchers examined Crohn's patients who were undergoing surgery for either Crohn's or for reasons other than inflammatory bowel disease. What is interesting is that patients with diseased Crohn's tissues had more than several hundreds times the amount of bacteria compared to patients with normal tissue. What this really would say is that there are different subtypes of Crohn's disease. Hopefully this research will result in more targeted therapies in the future.

Implantable Biologic For Crohn's Disease?
     A California company called SetPoint Medical has developed a very small device that can be implanted and somehow mediate the immune system to reduce inflammation for people with both rheumatoid arthritis and Crohn's disease. Below is a picture

   

Mid-Week Links: Crohn's and Sleep, Pellino3, John Hopkins Starts Fecal Transplant Program

Crohn's and Sleep
     In a new study published from Dr. Ananthakrishnan shows that poor sleep may be linked to a flare up in Crohn's. The study was collected by CCFA Partners (which I participate in) which is a study that sends out a periodic survey to Crohn's or ulcerative colitis patients. 50% of Crohn's patients even in remission reported sleep disturbances. I have some personal experience with this as on a Friday night I slept for 10 hours and woke up on Saturday feeling pretty great and almost felt I went into mini-remission.

Pellino3 Found For Crohn's
Researchers at Maynooth (Dr. Paul Moynagh) found Pellino3 could help patients with Crohn's disease and possibly protect people from getting it. The research team found that Crohn's patients have a lower level of Pellino3. The team is now trying to develop a drug that will target this in order to help Crohn's patients.

John Hopkins Launches Fecal Transplant 
     It looks like another medical center is getting into the fecal transplant game. The more places that offer fecal transplant the less patients will have to travel, wait, and worry about whether or not they can get their c difficile cured.

Weekend Links: Methotrexate Safe In Long Run, Mouse Model, Fecal Transplants, and Crohn Cancer Risk

Methotrexate Safe In Long Run 
A study shows that methotrexate is safe for Crohn's patients in the long run (and also beneficial). 63% of patients saw benefits after 1 year, which decreased to 47% at 2 years, and at 5 years only 20% of patients saw benefits.

New Mouse Model To Study Crohn's disease 

Researchers at McMaster University in Canada are using mice that have e-coli in them to study how inflammation affects the mice.

Crohn's Cancer Risk

In a study done in Norway the mortality and cause of death was looked at in Crohn's patients. The study looked over a 20 year period after patients were initially diagnosed with Crohn's. The study found no significant difference between Crohn's patients and regular people (about 14% of Crohn's patients died as opposed to 13% of the control group). 

FDA Backing Off Fecal Transplants

In a wise move by the FDA it said this past week it would no longer need agency approval before performing fecal transplants. I am glad to see the FDA did something wise for once. I estimated over regulating fecal transplants would have let thousands of people die and left even tens of thousands or more people in pain.

Fecal Transplants Come To Houston

This evening I received an e-mail from the University of Texas-Houston stating they were beginning to start fecal transplants for c difficile and for patients that failed conventional IBD therapy. The study being performed will see whether it is better to have fresh stools or frozen stools when doing the fecal transplants. Patients for c difficile have to have had 3 or more recurrent infections while IBD patients have to have had conventional therapy fail.

Dr. Herbert DuPont is heading a large fecal transplant program in Houston. He is Director of the Center for Infectious Diseases at The University of Texas Health Science Center at Houston. According to PubMed as I write this he has over 500 publications. He really seems to be an expert in c difficile and diarrhea.  His curriculum vitae is 71 pages long (he is a busy guy).

This is great news at now it looks like the FDA will be backing off major regulations which will allow more people to get this relatively effective and safe procedure. It will be interesting to see how many IBD patients are treated and the results. Dr. Borody in Houston has had success treating IBD patients (more on the ulcerative colitis side). However from the studies I have seen Borody did enemas multiple times instead of doing the fecal transplant via colonscopy or through the nose. At any rate this is great news if more people now can be exposed to fecal transplant and get rid of the debilitating and crippling effects of c difficile.

If you are interested in this procedure you can contact Dr. Dupont with his info here 

C Difficile Negative!!!, CCFA Meeting, 100th Blog Post

Well tonight I received good news. Dr. Khanna from the Mayo Clinic called me around 8 P.M. and confirmed I was c difficile negative (quick turnaround as I sent the stool sample on Monday morning FedEx overnight). The Mayo Clinic puts every other medical clinic to sham in terms of efficiency.  Of course this was of course after I had a fecal transplant which seems to have gotten rid of my c difficile however I have an underlying Crohn’s flare up. This flare up seems more mild than the last one I had around this same time last year. My GI wants to increase my Humira to every week. Tomorrow I will have to call him to confirm I that I no longer I have c difficile. However, I need to call the Mayo Clinic and see what they recommend for the Crohn’s flare up.

Tonight I also attended my first CCFA meeting. There were only around 7 men (I was the youngest person there). It was really interesting learning from different people what they use or have done. I was surprised to learn how many people went years before they were correctly diagnosed with Crohn’s or UC.  People have said Remicade has worked pretty well for them. It was interesting that a older gentleman who was around 70 years old just was diagnosed with Crohn’s after he took an antibiotic (surprised surprise). I mentioned that I don’t know of anyone who has Crohn’s or UC that has never taken an antibiotic. For me I had bronchitis right before I had Crohn’s.

Hopefully this good news will mean I can finally get on with my life in a flare up free environment.

This great news comes on my 100th published blog post. I have enjoyed blogging about my symptoms in addition to current research going on related to Crohn's/ulcerative colitis. For my own selfish reasons I have written this blog to help myself but hope it does reach others around the world and help others as well. 

One Week Post-Fecal Transplant, 1 Year Anniversary on Humira, and Getting A Little Better

So it has been just about a week after the fecal transplant. I have noticed some improvement in my condition (less tired, no more blood in stool, less cramping and pain, and the there seems to be less coming out of my bowel movements). Tomorrow I do a c difficle test that will be sent to the Mayo Clinic. However, with this said I am still having 4 watery bowel movements every day. I still am fairly hungry. My weight is around 145 right now (which is what I was at pre-Crohn’s however my weight is normally 152 or so). My mood depends on the amount of sleep I get. If I get a good night’s sleep I feel like I have less pain and cramping and feel more ready for the day. When I get less sleep I feel a little strain in my throat (however I have been using salt and warm water to make it go away). I started feeling better around Wednesday/Thursday and today drove for the first time in a couple weeks. Next week I plan to go back to work and have been off work for almost a month (I am eager to back). I still feel a little tired but not nearly as much when I was pumped with 3 liters of fluids.

My GI did a test to measure how much Humira (Promethus test which is a brand new test) was getting into my blood and he said it was on the low end. Over the past few months I have noticed when I injected Humira a bunch of liquid comes out. Perhaps I am not holding it in as long as I should have. This might be able to explain why I have a low level of Humira in my blood which might be why I have a current flare up. The problem is Humira can take a while to get into the blood system so I wouldn’t really know if my hypothesis is right until a few more weeks. Last night when I injected it I noticed no leakage whatsoever. Speaking of Humira it has been exactly a year since I started Humira. I think Humira has worked wonderfully so far. Perhaps the c difficile and possibly not injecting all of the medicine has derailed me from the right path.  My GI wants to increase my Humira dosage to every week instead of every other week. I asked about using Prednisone and he said we always have that in our back pocket. The long term use of Prednisone can have diasterous effects on the joints and muscles and even put people into wheelchairs. Also my GI mentioned the burdensome task of going to electronic records and had to take a 12 hour training course in order to learn for one hospital. He is no longer going to see patients at the hospital I was treated at originally in 2011 (he would have to learn two different electronic medical records systems and he said it isn’t work the time to learn).

On Monday if I am still having diarrhea I plan on sending a stool sample to Mayo to check to make sure I am still c difficile negative. If I am the Mayo doctors might want to talk about treating this Crohn’s flare up. No question this has to end. As my GI said I see us getting closer to the light at the end of the tunnel. An increase dosage of Humira might do the trick (along with doing it properly. 

Life After Fecal Transplant

So my symptoms I would say are a little better than before I had the fecal transplant. I have minor cramping but it is a shade below of when I had it before the fecal transplant. I feel a little tired but not nearly as bad as before I had the fecal transplant. I also don’t feel as dehydrated either.  My parents noticed that I don’t have to run to the bathroom right after I have a meal either which is nice. My bowel movements have decreased a little bit from the 5-6 times I was going before I had the fecal transplants. The Sunday after the procedure Dr. Khanna called me to see how I was doing. I told him I was still having diarrhea but felt a little bit better.

Bowel Movements Per Day

Friday (Day of Procedure)- 1 (after fecal transplant)

Saturday- 3

Sunday-4

Monday-4

Tuesday-4

Dr. Khanna called me back today and we agree he would send me a c difficle test kit to make sure I was still c diff negative. However he wanted me to wait until Monday to do it (given it will have to go via FedEx back to the Mayo Clinic. The idea is that you can’t treat c difficile with Prednisone if you have an underlying infection.

My situation is a little bizarre in a way. I don’t feel I am having a Crohn’s flare up because I remember how bad I felt when I did have a flare up. I was vomiting, I felt as if someone was stabbing my stomach, and pretty miserable. Honestly, I don’t feel 100% right now but I would say I am still much better today than I was last year when I had a flare up around this time. My personal observation is that I have pain 30% of the day while pain free 70% of the day. The pain is all below my belly button. 

Patient Number 44 for Fecal Transplant at Mayo Clinic

So today (May 31, 2013) was my fecal transplant. It was quite a long day. My fecal transplant appointment told me to be there at noon however the procedure didn’t start until closer to 3:00 P.M. Dr. Thomas Viggiano performed the procedure. The procedure went relatively well. Other than a nurse sticking my hand twice to place in the I.V. it was fine. During the fecal transplant the it was noticed that I was still having bowel movements during the procedure (I did drink plenty of water after drinking all the bowel prep).  He also noticed that I had moderate-severe colitis in my colon. However, I had a colonoscopy earlier this month done at Mayo at those were the same findings.  One question I would have is if the inflammation got worse. Also since the c difficile is doing harm on the colon. At any rate 250 cc’s of stool was inserted into my cecum and the idea is over time the healthy bacteria will find a new home and kill off the c difficile infection. I stopped vancyomycin and Dificid and will continue to do so.

The idea now is to wait and see how I do. Even though I had the procedure a couple hours ago I feel relatively good (however some of this might be the anesthesia). Right after the procedure I was given some cookies and water to hydrate and get some food inside of me. After I was all done I had a burger and fries (having to fast I was hungry but not as hungry as last time when I had to fast for 50 hours due to multiple tests). I have had to pass a little gas but haven’t had a bowel movement 5 hours after the procedure. Tonight, tomorrow, and this weekend will be a better indication. The goal now is to make sure I am c diff negative. If I am c diff negative then perhaps my Humira will have to be increased. 

Meeting With Dr. Sahil Khanna (Great Doctor) Before Fecal Transplant

So today was a pretty efficient day. We left our hotel around 11:30 A.M. and ended up at Mayo a quarter before noon. The blood test on my schedule was at 9:20 A.M., however you pretty much can go whenever to get a blood test. The only requirement was the blood test was 2 hours before our appointment. My appointment was scheduled for 4:15 P.M. We had some lunch (the only thing I could have was chicken broth which Mayo has in their cafeteria (since I am having my colonoscopy/fecal transplant procedure tomorrow). Since we got to the clinic early we had a question regarding the bowel prep. Our appointment was 4:15 P.M. and sometimes you don’t start until a little bit later and we just wanted to make sure I had the bowel prep tonight. So a nurse actually paged Dr. Khanna to ask him and he said he could met with us to discuss the fecal transplant procedure.

Dr. Khanna was very nice, intelligent, and really knew his stuff. He spent about half an hour with us. Much of the time was asking me questions about c difficile and Crohn’s history.  Dificid does have a 90% response rate. Dificid has a 15% recurrence rate. However, one problem with clinical trials is that it excludes IBD.

He then showed us pictures of the facility the fecal transplant was done in and also described the process. Mayo uses a $7,000 Stomacher blender which is pretty sophisticated. Dr. Khanna had mentioned some doctors at national meetings would say they were doing fecal transplants with martini mixers.

The screening process is pretty rigorous for the fecal transplants. Screening donor and donee are both tested for HIV, hepatitis, and syphilis. The donor also can’t have any medical problems. The donor has their blood and stool tested. The actual transplant is pretty interesting. It only takes about 5 minutes more than a regular colonoscopy because they have to inject the fecal material. After the fecal transplant possible side effects include: cramping, constipation, bloating, and possible farting (I haven’t noticed any of these). Best case diarrhea will completely go away. The fecal transplant has over 2,000 probotics while the most you can get out of a probotic is 4.

Non IBD patients 3 days IBD days 5-10 days resolution give it two weeks before it fails. Gradual improvement should be seen. So far Mayo has had 10 patients with IBD and c diff 6 out of 10 had resolution of all symptoms.  One question I had was if I did get sick again should I take an antibiotic and Dr. Khanna told me I should take Florastora when I take the antibiotic. He actually had one patient who had 15 rounds of antibiotics and took Florastora with it and didn’t have a recurrence of c difficile.

Dr. Khanna was nice enough to follow up with me on the Sunday after the procedure. I told him my symptoms and that I was doing a little better. I really appreciate Dr. Khanna and the Mayo Clinic team. 

FDA Meeting Workshop Transcripts With Fecal Transplant Doctors: More Regulation = Less Fecal Transplants

I found the transcripts from the FDA meetings in Bethesda, Maryland from May 2-3, 2013. Day 1 is here while Day 2 is here. If you add both documents it is over 600 pages. The first day wasn’t too interesting as it just the biology of fecal transplants and to be honest much of it I did not understand. The second day was more worthwhile because doctors who are actually performing fecal transplant presented what they have seen.  The second day included Dr. David Rubin, Dr. Lawrence Brandt, Dr. Colleen Kelly, Dr. Alexander Khoruts, and Dr. Hebert DuPont.

On the first day Dr. Allen-Vercoe creator of RePOOPulate from Canada only had two patients have done RePOOPulate and were saved by it as shown in this story. Canada is also much more friendly in terms in comparison to the FDA in regulating it as well. Actually RePOOPulate II is now being created and she is looking at it to treat IBD, obesity, and regressive autism.

Dr. Lawrence Brandt pointed out that the mortality rate of c difficile is 4% and jumps to 12% with a second infection of c difficile. The longest case he has had of c difficile has been 9 years.  For fecal transplants Dr. Brandt stops antibiotics (Dificid and Vancomycin) 2-3 days before the fecal transplant. Also Brandt reported the cure rate on fecal transplants is about 93% throughout the world.

Dr. Colleen Kelly reported that there are over 400 reported cases of fecal transplants in the literature however probably thousands performed (Dr. Borody as I pointed out here has done over 1,000 fecal transplants). She reports the success rate for fecal transplants after looking at 11 studies was 90%. To date Dr. Kelly has done 101 fecal transplants (ages 19-92). Of all these transplants 9 of them had inflammatory bowel disease. Kelly reports a 95% success rate. One patient that Kelly had who had ulcerative colitis (who I would point out was in his 70s) got a flare up after being off all his medications for 20 years. Kelly also pointed out that the labor required for one fecal transplant is equal to eight regular colonoscopies. On getting an Investigational New Drug (IND) (that the FDA grants) which she says was like learning a new language.  Dr. Kelly’s journey for the IND started in the fall of 2010 and wasn’t granted until 2012. In this process Kelly had to cancel 2 weeks of seeing patients and spend hundreds of hours working 12 hour days just to comply with the FDA to meet the IND.

Dr. David Rubin of University of Chicago mentions the FDA has been easy to work with yet challenging to work with at the same time. Rubin has been trying to study fecal transplants in ulcerative colitis patients.  He proposed it to his IRB (Institutional Review Board) who said they would give conditional approval but he still would need an IND.  Rubin had to submit a 206 page IND. The FDA had some suggestions and a new 168 page review was submitted.

Dr. Sachin Kunde who works on the pediatric side said that Mass General conducted a Phase I trial of looking at fecal transplants in IBD for children which lead to this study. Kunde discussed a study that looked at using enemas in pediatric patients with ulcerative colitis. What is interesting is close to 70% of patients had a clinical response by the end of the first month to the fecal transplant. Kunde in dealing with the FDA recommends hiring a study coordinator. Kunde’s IRB board also told her to stop what she was doing and get a IND from the FDA. She mentioned that the guidelines have been a challenge even after studying them for a year and a half.

Dr. Alexander Khoruts I learned is an advisor to CIPAC which is trying to commercialize full-spectrum microbiota for fecal transplants. Khourts’s first fecal transplant patient was a 61 year old woman who lost 40 pounds and having bowel movements every 15 minutes. Khoruts even had a patient who had c difficile for 12 years (recurrent infections). He also noted that IBD patients got better. In screening donors Khoruts uses a more rigorous approach then even the FDA (testing for more things, asking more questions, and is trying to standardize the donor process). Khourts himself spends an hour and half every day answering e-mails from c difficile patients.

Dr. Herbert DuPont who is prepared to set up a large fecal transplant program in Houston in association with the  University of Texas-Houston talked about the first fecal transplant he performed in 1970 (he is not a GI by training but an infectious disease doctor). DuPont who has been around a while talked about how things were done much more efficiently in the 1970’s when bureaucratic IRB boards were not around. No screening was done in those days. DuPont had a patent with severe antibiotic associated colitis and renal failure after a surgery. Vancomycin was used but didn’t work. DuPont then got immediate approval to do a fecal transplant. He used a blender and it was administered via retention enema to the patient. What is interesting is the donor was a typhoid carrier. However the patient who received the transplant did not get typhoid fever (it is hard to get typhoid fever from the rectum). In his transplant program DuPont wants to freeze the donor stool in order to standardize the procedure.

CEO Lee Jones of Rebiotix which plans to commercialize the fecal matter that can be used by doctors in fecal transplants. Jones has an IND for manufacturing, creating, and delivering the fecal material. The IND ran 1,500 pages. The company plans to have their product out by 2015 (assuming the FDA doesn’t delay this a few years).

Dr. Jay Slater who works for the FDA says the IND is hard yet very doable (too bad he doesn’t have to fill one out).  Doctors have told Slater how painful the experience of IND is and his response is “it’s definitely something that’s hard, it’s hard for a reason, and it’s very doable”. Also for an IND three phases are required just like for regular drugs.

The FDA is being overzealous as usual when it comes to fecal transplants. Fecal transplants have a cure rate of 90% with no serious adverse side effects (thousands have been performed). Filling out endless paperwork, constantly having to send the FDA data, and having meeting after meeting with the FDA doesn't help the patients truly in need of fecal transplants. With the new IND regulation fewer people will be able to get this life saving treatment and may possibly get worse and or die (which is pretty tragic). Dr. Kelly mentioned she spent hundreds of hours just simply trying to comply with the paperwork which is crazy. How on earth is the FDA going to regulate something they are not experts in? Having to go through three phases of clinical trials for fecal transplants will take many years (meanwhile people will be suffering). The doctors that have performed fecal transplants are the most knowledgeable on the whole procedure. A better way would be to have doctors who are performing them share their protocols and methods with each other in order to develop best practices. 

FDA Proves Utter Incompetence in Regulating Fecal Transplants: 2,000 People Will Die As A Result

Recently the FDA issued vague and unclear ruling on regulating fecal transplants. When I first saw this I was quite enraged, upset, however not too surprised. On May 2-3, 2013 the FDA held a conference which was preceded by this letter in Bethesda, MD to talk to doctors who were performing fecal transplants.  The FDA is now requiring an IND and treating fecal transplant as a biologic which has pushed back fecal transplant for nearly everyone by 2 months. In reality it will take 2 months for the FDA just to get around to this subject let alone do anything about it.  If 14,000 people die from c difficile every year that would say that the FDA will contribute to the death of over 2,000 people.

What is quite interesting is that fecal transplants have been performed since 1958 yet I have never heard of any serious adverse affects or deaths. According to a 2011 ACG meeting about 5% of patients who received fecal transplants also contracted an autoimmune disease after they got the fecal transplant. However it is hard to say if it was from the fecal transplant or something else. It is important to remember that people do actually die from c difficile. In fact the New England Journal article from this January showed that 94% of patients were cured of c difficile compared to the only 31% who received vancyomycin. Even the people running the study said it was unethical to not give the patients fecal transplants.

Dr. Mike Edmond might be the only doctor with some sense on this matter. Basically from the way he explains it doctors will have to apply for an IND number (doctors have to submit their protocol). Then maybe 30 days after the FDA gets the information they will let the doctors know if they can proceed. The FDA won’t even let doctors know what they are looking for.

Just how incompetent is the FDA? Here we have a treatment that cures 80%-90% who have a life threatening illnesses with the only existing therapies being antibiotics such as Dificid and Vancyomycin which can costs thousands of dollars while the fecal transplant is much cheaper. Thousands of fecal transplants have been performed as well.  However there never seems to be enough data for the FDA. Perhaps the FDA is incapable of performing a cost/benefit analysis. Actually the most expensive part of the fecal transplant is testing the donor’s stool. However, since the FDA has not approved fecal transplants insurance companies won’t cover it.

The result of the new FDA ruling on fecal transplant will cause more paperwork for doctors, more bureaucracy, more patients having to suffer, and more people dying because the FDA doesn’t seem to think anything is safe enough. 

Fecal Transplant Cures C Difficile! Fecal Transplant for Crohn's and Ulcerative Colitis

Recently, this New England Journal article came out showing that 100% of patients who had a fecal transplant for clostridium difficile (c difficile) saw improvement. Usually the treatment for c difficile is taking vancomycin which can cost $55 per ill (ending up costing $2,000 or more over the course of treatment).  This is great news for people with c difficile. Upon doing further research I learned that this procedure now is being experimented on (not formally though for patients with ulcerative colitis and Crohn’s disease). One great piece of literature I found was this meta-analysis which essentially looked at every single study done on fecal transplants for inflammatory bowel disease. Nearly all the studies so far have only been for c diff and not for inflammatory bowel disease.  One conclusion from the meta-analysis was there was a reduction or complete resolution of symptoms in 76% of patients and prolonged remission in 63% of patients.

Dr. Thomas J. Borody seems to be an expert in fecal transplants. He is based in Australia and has done some good research in the area. He did his first transplant according to this article in the 1980’s on a woman who had incurable colitis. It seems after the transplant her colitis never came back. What we need is more experimentation like this in order to get medical advancements. The problem today is the red tape involved with the FDA or federal government that prevents people like us from getting the treatments we need. Borody has performed over 1,500 transplants and currently does 5-6 fecal transplants a week (most are for irritable bowel syndrome which I actually was diagnosed with in February of 2012 in the same year I had Crohn’s). He has even use fecal transplant for non-stomach related issues like acne, multiple sclerosis, and even people with Parkinson’s disease.

In this study of 6 people that Borody conducted with ulcerative colitis all 6 had no signs of ulcerative colitis after 13 years! I looked on Dr. Borody’s website and it seems you can get a fecal transplant for $12,000-$15,000 (in Austrilian dollars which is about the exact same as American dollars) which is just for the transplant and doesn’t include travel or even nursing care. If this could really could help “cure” Crohn’s I really would consider it. However, there are too many unknowns like a) will it work b) how long may it work c) possible side effects and complications. One major problem in the United States is that the FDA has not approved fecal transplants which makes it hard not only to help people but increases the costs of fecal transplants. Insurance companies will not often pay for something that isn’t approved by the FDA or lacks evidence. As more data comes it showing that fecal transplants can help c diff patients that will change. However, we need experimentation with other conditions like Crohn’s, ulcerative colitis, and other autoimmune diseases to really get the ball rolling.

Other doctors in the United States have performed fecal transplants as well. Dr. Alexander Khoruts of University of Minnesota has performed over 130 procedures according to this article. Dr. Colleen Kelly has performed 45 procedures according to this article. Dr. Lawrence Brandt has performed 17 of these procedures (he has been doing it since 1999), while Dr. Christina Surawicz of the University of Washington has performed 16 procedures. Dr. James Versalovic of Baylor College of Medicine in Houston plans to start a intestinal microbiome transplantation program.

Due to the fact that fecal transplants are not approved yet many people are doing it themselves at home. I found and interesting website where a guy who had ulcerative colitis for 12 years did at home fecal transplants and now is in complete remission (he started feeling much better only after 2 days). This sounds good to some people but I personally worry about whether people are doing it correctly, the risks involved, and these people are also not screening the poo that they use to transplant which can present risks.  Right now donors are usually family members or relatives since their medical condition is usually known. The largest cost of the whole procedure is screening the donor which can cost $1,000 according to this article.

This article discusses how the fools at the FDA seem confused since “feces” doesn’t fit into anyone of their main categories. We need many doctors and patients experimenting with fecal transplant in order to spread knowledge of the best way of doing the procedure. Knowledge is power. It looks as if fecal transplants may have a role in ulcerative colitis but time will tell if it can help for Crohn’s. I would also wouldn’t mind seeing a market for feces where people could give it and collect money for it like they do for sperm or blood. Companies could pop up that would screen the feces and could grade it and let people decide which kind they wanted to supply. I have a feeling drug companies might be interest as well because they pay be able to find a mechanism that works similarly like feces to give the same result. Given there are 500,000 cases of c diff every year we will need a lot crap. Also it would be interesting to see if fecal transplants can help other autoimmune diseases like psoriasis, rheumatoid arthritis or other things like acne, Parkinson’s. Every day that goes by is another day a patient suffers. People need to get over the gross factor and we need to start doing things that are proven to work.