You can’t blame Patient #1 for not wanting to share his name; he’d rather not be known as the guy who swallowed poop in the name of science.
But he does want you to know he is willing to go to extremes to help find a cure for Crohn’s disease, an autoimmune disorder that causes severe abdominal symptoms and robs his body of nutrients.
It’s not as crazy as it sounds. Fecal microbiota transplantation (that’s right – fecal, as in feces, as in poop) is a tried-and-true treatment for recurrent bouts of Clostridium difficile infection (or C. diff), a dangerous intestinal bacteria.
It works by repopulating the intestinal tract with “good” bacteria, which are often wiped out by the antibiotics used as the first line of defense against C. diff.
What’s not known is whether fecal transplant can also help patients with inflammatory bowel disease, like Crohn’s disease and ulcerative colitis.
A team at Seattle Children’s – led by gastroenterologist David Suskind, MD – is carrying out a clinical trial to answer that question.
First center to test fecal transplant effectiveness in pediatric patients
Children’s was the first research center in the nation to receive federal approval to test the effectiveness of fecal transplants in pediatric patients with inflammatory bowel disease, and it is the only center studying the treatment in children with Crohn’s disease.
More than a coincidence?
As is often the case, this clinical trial was inspired by a patient’s clinical experience.
About a year ago, the Gastroenterology team used fecal transplant to treat a stubborn C. diff infection in a patient who also had ulcerative colitis. “The patient’s C. diff infection improved,” says Suskind. “Even more significantly, the patient’s inflammatory markers went down, a sign that the ulcerative colitis had also improved.”
Was it just a coincidence? To find out, Suskind needed to test the treatment in other patients.
Within nine months, he had approval from the Institutional Review Board at Seattle Children’s Research Institute; permission from the U.S. Food and Drug Administration to proceed with a clinical trial; and funding from Seattle Children’s Academic Enrichment Fund.
The goal is to study 20 patients, ages 12 to 21, who have mild to moderate disease.
Patient #1 fit the criteria
The 19-year-old college student has been living with Crohn’s disease – and coming to Children’s for care – since his sophomore year of high school. When it flares up, the illness lays him low with pain and diarrhea.
“Crohn’s is a big part of my life,” he says. “I had to stop a lot of physical activities in high school, like sports. And I didn’t do as well academically my junior and senior years because stress makes my symptoms worse.” The disease typically sidelines him from school for a week or two each year.
Medications to control the symptoms work at first, he says, “but eventually the effectiveness wears off and I have to switch.”
He was on his third medication when Children’s got the go-ahead for the fecal transplant trial. He was the first patient to enroll.
“This offered something besides regular medication,” he says. “Even though it might not benefit me, I didn’t see how it could hurt. And I like the idea of helping move the science forward.”
He was undaunted by the “ick” factor. When you’ve lived with Crohn’s disease long enough, he reasons, you get used to dealing with poop.
No taste, no smell
Unlike an organ transplant that requires surgery, fecal transplant is a pretty simple procedure, explains Suskind:
• Stool is donated, usually by a family member, and is screened for infection.
• The patient prepares for the procedure by taking antibiotics and a laxative.
• A solution of donor stool mixed with saline is administered through a tube running from the patient’s nose to their stomach (this takes about three minutes).
• A half hour later, the patient goes home.
“Dr. Suskind distracted me while they put the stuff in the tube, and I didn’t even notice it going in,” says Patient #1. “There was no smell and no taste, and it was over pretty quickly.”
All in all, it’s simple and low-risk, says Suskind.
“Fecal transplant has been used to treat C. diff in patients from 2 to 90 years old with no overt side effects,” says Suskind. “While there’s a hypothetical risk of transferring an infection, our screening procedures vastly reduce that risk.”
Patients come back for check-ups and lab work two, six and 12 weeks after the procedure.
Patient #1 felt better after the transplant, and blood tests showed a dramatic drop in his inflammatory markers at his two-week and six-week follow-up visits.
These preliminary results give Suskind and his team reason to be cautiously optimistic.
“Trillions upon trillions” of bacteria
While the researchers try to figure out whether fecal transplant helps patients with inflammatory bowel disease, they’re also trying to learn why these diseases occur in the first place.
“We have more bacteria in our bowels than we have cells in our bodies – trillions upon trillions of them,” explains Suskind. “Our best guess is that in individuals with inflammatory bowel disease, bacteria that are not healthy for the gastrointestinal tract take hold, triggering an immune system response that results in inflammation of the lining of the intestine.”
That inflammation can lead to debilitating abdominal pain, diarrhea, growth failure and nutritional deficiencies.
But why, exactly, does this autoimmune response occur in some people and not others? And, precisely which bacteria are involved?
“As yet, nobody knows for sure,” says Suskind. But that is sure to change.
“This is a golden age of research for inflammatory bowel disease,” he says. “A lot of research coming out now is helping us better understand the tremendous diversity of bacteria that live in our bowels.”
Children’s fecal transplant study will be an important addition to the body of evidence.
“We don’t know yet if this works – and if it does, we don’t know whether it will completely transform the intestinal biome in the long run,” says Suskind. “That’s why our patients are so important. They are the key to answering the questions.”
Note: The U.S. Food and Drug Administration recently told NBC News and other outlets that they now require doctors and clinics that perform fecal transplants to apply for investigational new drug applications, known as INDs, in order to continue their work. Dr. Suskind told On the Pulse that Children’s has an IND for its study.
To arrange an interview with Dr. Suskind, contact the Seattle Children’s public relations team at 206-987-4500 or via press@seattlechildrens.org.
Update: Seattle Children’s is no longer doing this trial. The results are being analyzed and will be reported on in the future.
Is the team opposed to trying this out for patients with other GI problems besides IBD and Crohn’s? I would be SOOOO happy to go on my son’s safe diet in order to try something like this in the hopes of it helping at all.
Thank you for reading the story, Alison. Dr. Suskind said that while he does think bacteriotherapy may be beneficial in other conditions, we are not currently treating any other conditions with Fecal Microbiota Transplantation (another name for the procedure).
Are you still looking for patients for this clinical trial. My daughter fits the criteria (ulcerative colitis, diagnosed 6 months ago, 20 years old) and is willing to try it.
Thank you for reading this blog post and for your question, Colleen. I’ll send you a follow-up email. Dr. Suskind said he’d be happy to chat with you.
I also have a daughter that would be interested in being part of this study. She is 12 years old and has a mild to moderate case of ulcerative colitis. Please advise. Thank you.
Margarita – Thanks for your interest in this study. I’ve sent you a follow-up email. Dr. Suskind would be happy to talk with you.
Thank-you for sharing information about the work you do. I would be interested in speaking with Dr. Suskind as well. My daughter (12) was diagnosed with UC in June after a hospitalization in May, then Crohn’s this month after capsule endoscopy. We are very interested (both read the interview on Comfy Belly) in this direction of research and treatment.
Erin – Thanks for reading the blog post and for your interest in Dr. Suskind’s work. I’ve shared your contact information with him and he’ll contact you directly.
Hello Meghan,
Our 15 year old daughter was diagnosed with Crohns a little over one year ago. It is in the moderate stage. It looks like our soon to be 11year old son is unfortunately headed in that direction as he has a lot of stomach aches and is losing wt. We are are struggling as a family and would be very interested in the fecal transfer for our daughter since she is in the age range for the study.
Hi Barb – Thank you for your note and interest in learning more about the study. I’ve passed along your contact information to Dr. Suskind and he will be contacting you directly, shortly.
My son had classic symptoms of Crohn’s disease at age 10, and his doctor finally diagnosed him with Crohn’s Disease at age 15. He is now 17. We have interest to participate. Can the clinical trial be done in a Japanese hospital, or would we need to travel to Seattle?
Thank you for sharing the details of your son’s diagnosis and for your interest in Dr. Suskind’s research. The clinical trials that he is conducting are full at this point, and Dr. Suskind hopes to share results in the next few months. I’ll share your contact information with him and he will be in touch during the next phase of his research.
Hi. I have a 10 yo son who was diagnosed with Crohn’s at age 9. He’s doing well on a combo of methotrexate and humira, but that’s a pretty potent cocktail of chemicals. I’ve been fascinated by the potential of fecal transplants some time now, and I”m thrilled that it’s seriously being studied among pediatric patients. He would have been too young for the current study, but if this study shows promise will there be more? Or access to the procedure?
Thank you for reading about Dr. Suskind’s research and sharing your personal story. Dr. Suskind said that he hopes to share results from the study in the next few months and is planning to expand his research based on what he’s seen so far. If the next study confirms a positive effect, Dr. Suskind said that we should be opening up the research to younger patients.
My wife was diagnosed with Crohns. Are you aware of any clinical trials for adults in the Seattle area?
Thank you for reading about our research. The Fred Hutchinson Cancer Research Center announced a new clinical trial for adults with Crohn’s disease in July 2012. See the Fred Hutch release for more information.
I am curious if Dr. Suskind has any recommendations for gastroenterologists that do this type of therapy near Portland, OR? Or has a recommendation for a trusted gastroenterologist in Portland that has an open mind when it comes to diet and methods other than medicine to help my ulcerative proctitis? I also have autoimmune pancreatitis type 2, which every doctor that I have been to tells me they can do nothing about. My pancreas continues to atrophy. I am feeling defeated and reaching out to see if Dr. Suskind may have any recommendations.
Per my previous post…I forgot to mention that I am a 33 years old.
Thank you for reading about Dr. Suskind’s research. According to Clinicaltrials.gov, the closest center conducting similar research for adults (and actively recruiting) is at the University of Washington. I checked with our Dr. Matt Giefer on the pancreatitis question. He said that Dr. Dick Kozarek at Virginia Mason here in Seattle is one of the leading pancreas experts in the world. You may want to reach out to him with your question.
My 10 year old daughter is not responding well to drug therapies. We are very interested in the possibility of a trial for younger children. We live in NC and are wondering if her pediatratric GI could be involved in trial here and share results. If not, we can travel if she would qualify. Thx!!!
Thank you for sharing the details of your child’s diagnosis and for your interest in Dr. Suskind’s research. The clinical trials that he is conducting are full at this point, and Dr. Suskind hopes to share results in the next few months. To watch for future trials to open up, please check ClinicalTrials.gov.
My 13 year old daughter was diagnosed with moderate UC a year ago. She has responded very badly to all of the traditional medications; she had the rare 1% side effects to each medication. What are our options at Seattle Children’s?
Thank you very much for sharing the details of your child’s diagnosis. The clinical trials that Dr. Suskind is conducting are full at this point, and he hopes to share results in the next few months. To check for other trials that may be open, please check ClinicalTrials.gov. For questions about what other medical options may be available, please contact our Gastroenterology program at 206-987-2521.
Two years ago my 14 year old daughter was diagnosed with Crohn’s. Although I live in New York, I’d be interested for my daughter to participate in Dr. Suskind’s clinical trial. So far, I haven’t heard of any such studies for children on the East Coast- Have You?
Thank You
Thank you very much for sharing the details of your child’s diagnosis and for your interest in Dr. Suskind’s research. The clinical trials that he is conducting are full at this point, and Dr. Suskind hopes to share results in the next few months. To check for other trials that may be open or to watch for future trials, please check ClinicalTrials.gov.
Steven – I live in NY, too. I have started discussions with doctors at Columbia. I am in the book. Call if you want to compare notes.
We would also be interested in participating in upcoming trials. My 13 yo has UC. Is there is list that we can be put on?
Also, in reviewing the clinicaltrials.gov site it looks like Baylor will be doing a study on UC and fecal transplantation. Is there a difference between the one that was conducted at Childrens-Seattle and this upcoming study at Baylor?
Happy Holidays!
Thank you very much for your interest in the clinical trial. At this time, we are not enrolling new patients, but please watch for another study to open on clinicaltrails.gov. For specific information regarding studies at other institutions, please reach out to the appropriate contacts listed on clinicaltrials.gov.
My 13 year old was diagnosed two years ago at age11 with Crohns in his small bowel. He has responded well to enteral nutrition (orally – 5 shakes a day), but realize this treatment will be hard for him to continue long-term. My husband and I are very fearful of some of the other drug therapies out there and really buy into the gut bacteria theories getting more attention now-a-days. We’d love to hear about any trials in the NYC area for him.
Thank you for your inquiry Angelina. To see what trials may be open in the New York area, please check ClinicalTrials.gov. For other medical questions, please contact our Gastroenterology program at 206-987-2521.
Any update on the results of the trial?
The results of the study are currently being submitted to a medical journal and we will share the full results when they are published. Overall, while more research needs to be done, the results were positive for Crohn’s disease.
I am interested in meeting with Dr Suskind about my daughter. She did not respond to remicade, and has had cdiff 4 times this year since June. I have tried repeatedly to get fecal transplant from our GI but still had to give her vanco taper. It has caused a horrid flare, just left hospital after week stay for blood transfusion, TPN and iv steroids and antibiotics. I know her Intestinal bacteria is completely off and yet we are encouraged to try humira again. Our GI does not think diet plays a major role, just told to keep diary. I am calling this week to see if we can get my girl in this summer! You give us hope!!
I am interested in FMT for my 16 year old daughter with UC diagnosed this summer. She also had CDiff. We are planning to get our MD to refer us to Dr. Suskind as soon as possible.
Hello
My 2 1/2 yr old nephew was diagnosed with Crohns at 22 months (Feb 2015) – they found 52 ulcers after doing a scope both ways (sorry I do not know the proper terminology)…….we live in Vancouver and tests have been sent to US for confirmation / further testing that Canada does not have in place. Last week (Sept 2015) he was diagnosed with C diff….so very sad…..my brother also has a 4 month old. I suffered with C diff for 2 years but what my nephews and my brother’s family is going through is a complete night mare. Any suggestions, I imagine Dr Suskind would be a blessing to our family.
Hi:
My 23-year-old son was diagnosed with Crohn’s a few weeks ago. He also has ankylosing spondylitis – a form of arthritis related to UC/Crohn’s, which was diagnosed at 14. I have UC, my mother has psoriatic arthritis and my father had ankylosing spondylitis – so there’s little doubt my son inherited the markers through me.
In any case, I was looking into FMT for myself a couple of years ago – instead, I turned to high levels of probiotics and have been in remission for 18 months.
I would love to speak with someone about getting FMT for my son as I don’t see him making the diet commitments I did that (I believe) put me in remission. Is there someone I can speak with? Or are there current trials he can apply to?
Thank you for your help.