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Current FMT Clinical Studies with Inflammatory Bowel Disease Focus

If you are thinking no way i took this picture today…You are right…way the heck too cold in Prague right now for this type of gear…but this was back in September three months back..close enough eh!! -adam

 

Dear UC’ers and Fellow Followers of the iHaveUC Site,

I was diagnosed with ulcerative colitis 2,992 days ago.

Back then, there was very little talk of fecal microbiota transplants, sometimes referred to now as FMT.

Much has changed, FMT is growing, it has been growing, and every once in a while, it makes it to the headlines of national news portals and TV stations for that matter!  Pretty incredible indeed.

If you are new to FMT, and wondering what the heck it is…don’t worry you’re not alone.

Most newly diagnosed colitis folks, and even some old timers are not really sure what these three letters when put together stand for.

Here’s a quick idea:

  1. Somebody takes a poop (aka the “pooper)
  2. Somebody else takes that poop, and somehow gets it in their colon (aka the “poop receiver”)
  3. The result, is a whole bunch of bacteria from the “pooper” getting into the colon of the “poop receiver”
  4. And…hopefully the new bacteria that is received calms down some or all of the digestive problems that the poop receiver was dealing with before. (This can get quite complex and full of opinions/science/ideas for sure).  I happen to believe quite a bit of the “new age” thinking on this, and, as I am a firm believer in gut bacteria imbalances being part of our disease and the symptoms some of us deal with, its not some far off thinking in my view. (Many doctors, and many well respected GI doctors do not feel the same, feel free to talk with yours about this, or even feel free to check out the FMT interview I conducted with two doctors a little while ago here – FMT interview question and answers.)

Here’s an online definition that you might like more…:

Fecal Microbiota Transplant (FMT) is a procedure in which fecal matter, or stool, is collected from a tested donor, mixed with a saline or other solution, strained, and placed in a patient, by colonoscopy, endoscopy, sigmoidoscopy, or enema.
There are quite a few stories that have been posted to the iHaveUC site about FMT you can check those out here – FMT Stories.
But the purpose of this story is to give a break down of what is happening in the clinical world with regards to FMT “clinical trials” right now.  So below is a listing of just a few of them.  You can search the entire list here whenever you like:
FMT Clinical Trials Details from US National Institute of Health Database

Current Clinical Trials Regarding Fecal Microbiota Transplants and IBD:

  1. Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease (SFMT-IBD). 
    Purpose: There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn’s disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.
  2. Manipulating the Microbiome in IBD by Antibiotics and FMT (FMT)Purpose: 

    The etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut microbiome. The results of previous studies on the effectiveness of antibiotics and fecal macrobiota transplantation (FMT) are contradicting.

    Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy (UC and isolated “UC-like” Crohn’s colitis). The secondary aim is to assess the outcome of FMT in those not responding to five days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant disease to at least two immunosuppressive medications, may be treated with either interventions.

  3. Pilot Study of Fecal Transplantation Using a Unique Diet for Donor and Recipient in Moderate to Severe Treatment Refractory Colitis in Inflammatory Bowel DiseasePurpose: 
    Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn’s disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially prolonged remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients, however in the first pilot stage The investigators will enroll 34 patients, and extend the study if there is a trend for better outcomes with the dietary conditioning protocol. Furthermore, The investigators hope to identify successful donors during this period to use during the study extension.
  4. Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel DiseasePurpose: 
    The gut microbiota is determined to constitute a “microbial organ” which has pivotal roles in the intestinal diseases and body’s metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria flora and inflammatory bowel diseases. Lots of studies showed its efficacy in treatment of severe Clostridium difficile colitis. Corticosteroid dependence in patients with ulcerative colitis (UC) and Crohn’s disease (CD) is an important clinical problem and maintenance of steroid-free remission is a key treatment goal. Early studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC) and Crohn’s diseases have also met with success. This is an first step into investigating the potential efficacy of standardized FMT through terminal ileum for UC and CD, the investigators propose to determine the efficiency and safety of FMT in a series of 80 patients with moderate to severe UC and CD.
  5. Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative ColitisPurpose: 
    The primary aim of this phase I/II, randomized, placebo controlled study is the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30 years) with active ulcerative colitis (UC) who have previously failed traditional, first-line maintenance therapy (aminosalicylates) or are intolerant to therapy. Secondary objectives include the identification biomarkers in both donor and recipient that may confer a clinical response and to establish whether or not ongoing FMT maintenance therapy is required for maintenance of clinical benefit in pediatric UC.
  6. The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis (FMT_UC)Purpose: 
    Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double blind, placebo controlled study. The safety and efficacy of the intervention will be closely monitored.
  7. Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis (FMT)Purpose: 
    The investigators will test the hypothesis that giving antibiotics prior to fecal transplant therapy for active UC increases the proportion of patients in remission at the end of treatment. The investigators will randomize patients aged 18 or over with active UC to antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for two weeks); or identical placebo. At the end of two weeks the investigators will give all patients fecal transplant therapy twice per week for eight weeks from the donor whose stool showed most efficacy in the trial (donor B). Patients will complete a validated UC questionnaire, have a flexible sigmoidoscopy to assess the degree of inflammation in the colon and complete general and disease specific quality of life questionnaire as well as a questionnaire on anxiety and depression. Patients will complete the same questionnaires again at the end of treatment at week 9 when they will also have a repeat flexible sigmoidoscopy. The main outcome that will be assessed is the proportion of patients in remission from their UC at the end of treatment.

So there is a pretty decent list of some of the FMT related trials that are going on right now.

Thank you to the reader of the site who emailed me requesting some details on what is going on with FMT!  Much appreciated, and I hope this will get some people motivated to do some more research on your own.  Changing the gut bacteria for the better has been a major MAJOR component of my life for nearly 7 years now since I started using the diet that I follow to treat my UC, and heck, we might all be taking poop pills before we know it to do the same.

Enjoy the week ahead, and wishing those of you in the middle of UC symptoms a quick end and return to normal before we start the new year,

Adam



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