Mid-Week Links: Increase Pediatric Rate For Crohn's, Mayo Opens C Diff Clinic, and Crohn's Man Has Colon Removed Is Able To Swim...

Increasing rates of pediatric Crohn's
     My heart always goes out to children who get Crohn's. I was diagnosed with Crohn's when I was 26. However, I really don't know how bad it would be to be a young kid and be told you have Crohn's. This study shows that from 2000-2009 the hospitalization discharge rate for Crohn's increased 59% while the percentage for ulcerative colitis increased 71%.

Mayo Clinic Opens C. Difficle Clinic
     I am glad I received my fecal transplant at the world class Mayo Clinic in Rochester, MN. I am pleased to see that the Mayo Clinic is now opening a c difficile clinic.

Crohn's Man Swims Across Lake Erie (Without Colon)
     In this great story Ryan Stevens (who suffers from Crohn's disease) had 5 feet of his colon removed (temporary ileostomy which was later reversed). This article shows a picture of Ryan in the pool and you barely notice any scarring from the surgery. Ryan is raising money for Crohn's. Ryan has his own website too.

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 

Humira Every Week Now

So this past Friday I started my increased dosage of Humira (from every other week to every week). It takes Humira a while to get into the bloodstream and my GI said to call him back within a few weeks to see how I was doing. Last night when I injected my shot I noticed that again nothing leaked out (just like the last time I administered the shot). I had talked to my GI to see if I was administering it properly and actually someone from a at home nursing company can come to the house to make sure you are doing it properly. I also learned that Remicade can also be administered in the home setting as well (hope I won’t need this for a couple of more years). I would think increasing the dosage of Humira and administering it properly will get more Humira into my system.

On a Humira related note a nurse had told me I should look into a program Humira has that can offer discounts on the medication if you qualify. The program is known as the patience assistance program and to my knowledge there really is no financial testing they actually do. Right now I pay $200 for a 2 month supply of Humira which is shipped through Accredo (speciality pharmacy of Medco). When I spoke with Humira they had said they could look at what I pay now and see what I would pay under this program. People can pay anywhere between $5 and $500 depending on their insurance. I will find out more about this on Monday.

My symptoms are the usual (diarrhea, some pain, and tired). On Friday night I did notice some arthritis in my hands and arms somewhat (although I was laying down for a few hours). I have had signs of this in the past little but last night it seemed to show up more. Usually it goes away pretty quickly though and I never notice it during the day.

Today (Sunday) I felt pretty well and had a little less pain than usual. I did consume a large sundae last night and had a few bowel movements after it with some pain. Perhaps me correctly injecting myself is starting to work somewhat. The true test will be once my diarrhea stops though. 

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. 

Another Trip To Mayo Clinic For Fecal Transplant (Days 1 & 2)

Today (May 28, 2013) I traveled to Rochester (with my father of course) for my fecal transplant at the Mayo Clinic scheduled for Friday (May 31, 2013). As usual we took United Expressjet to Minneapolis and then a shuttle (about an hour and 20 minutes to Rochester). We were actually suppose to leave on Wednesday for our trip but we noticed the bad weather in the Midwest and decided to go a day early. The fight wasn’t too bad (a little bumpy) but I have had worse. This time we are staying in the Aspen Suites which seems more comfortable then the last place we stayed at.  There is a place called the Canadian Honker right next door which was pretty good. Tonight I had a roast beef sandwich and some beef vegetable stew followed my diarrhea an hour or so after.  I really didn’t anything today until dinner because I worry if I eat I usually have to go to the bathroom pretty soon after I go.  My energy level comes and goes. At times I feel really tired during the day and around midnight I start feeling great without any pain. Last night (Memorial Day) I ate a bunch of cheese cubes.  Also I had a burger which might have been too greasy for my stomach. The name of my name this week is going light and easy on the food.

I am someone anxious, nervous, and a little excited about the experience. The best way I can explain is oddly enough taking a final exam. You go through a long and grueling many months and then finally you see if what you have been doing actually works. In this case I have had c difficile since January 6, 2013 (semester start) and this is about the same time school gets out. 

I know I have some doubt as to whether or not the fecal transplant will work. I would be willing to even do a second fecal transplant if the first one doesn’t work. If two fecal transplants don’t work then perhaps another game plan will be needed. Oddly enough I am also somewhat aware I do have a very very very small chance of not being here if I still have the c difficile.  I also worry about developing serious complications between now and then like sepsis, a megatoxic colon, and perforating my bowel. Although, I guess statistically speaking my chances of all these complications decrease every day.  I hope that nothing catastrophic goes wrong. Once I start doing the colonoscopy prep on Thursday hopefully things might fall into place.

Day 2 at The Mayo Clinic

So on the second day of our trip nothing too exciting happened. Me and my father went to Wal-Mart to get some water, soap, and some other things. The bus to Wal-Mart made multiple stops and it took over 40 minutes to get back to our hotel even though it was only a 7 minute trip. For dinner we went to a place close to our hotel called Café Presto I had a burger and fries. Then for dessert I headed over to the Canadian Honker and had a very good sundae (last thing I will eat before colonscopy).

Tomorrow I have an appointment with Dr. Sahil Khanna. I am looking forward to see what he has to say about my situation and the fecal transplant.

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.