Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 7/11/2018 |
| Start Date: | December 2015 |
| End Date: | September 2018 |
The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant
(FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the
expanding choices of medication for UC, physicians and patients are still in search of highly
effective and safe medications with minimal side effects. FMT has been approved for the
treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has
been proven to be an effective and safe alternative therapy with zero reported serious
adverse events from patients that have had this treatment.
The providers that are conducting this study hypothesize that delivering microbes from a
healthy human gut can help treat the damages caused by UC. This is done by "transplanting"
fecal material, which contains a highly complex and dense community of healthy microbes,
including bacteria, fungi and viruses. This collection of microbes is referred to as a
microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.
(FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the
expanding choices of medication for UC, physicians and patients are still in search of highly
effective and safe medications with minimal side effects. FMT has been approved for the
treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has
been proven to be an effective and safe alternative therapy with zero reported serious
adverse events from patients that have had this treatment.
The providers that are conducting this study hypothesize that delivering microbes from a
healthy human gut can help treat the damages caused by UC. This is done by "transplanting"
fecal material, which contains a highly complex and dense community of healthy microbes,
including bacteria, fungi and viruses. This collection of microbes is referred to as a
microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.
Inclusion Criteria:
- Men or women 18-75 years of age.
- Established diagnosis of ulcerative colitis (UC) with known involvement of the left
colon
- Mild to moderate disease defined as endoscopic evidence of disease with Mayo
endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score
ranges from 0 to 12, with higher scores indicating more severe disease. This score can
be used for both initial evaluation and monitoring treatment response).
- Patients may be on any class of IBD-related medication (excluding steroids)
- Patients must be on stable medication regimen for at least 6 weeks prior to
enrollment.
- Ability to understand and willingness to sign informed consent document
Exclusion Criteria:
- Patient who are asymptomatic
- Patients with severe, refractory disease (defined as Mayo scores of > 10, or
endoscopic disease activity score of > 3) or patients with any other significant
condition which, in the opinion of the investigator, could confound or interfere with
evaluation of safety, tolerability of the investigational treatment or prevent
compliance with the study protocol
- Prior colectomy
- Positive stool test for any of the following: Clostridium difficile by PCR,
Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard
stool culture.
- Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
- Systemic antibiotic use within prior 6 weeks to enrollment
- Regular probiotic supplement use within prior 48 hours to enrollment
- Pregnancy or breastfeeding
- Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation
therapy)
- History of anaphylaxis (severe allergic reaction)
- Documented allergy to fluoroquinolones, metronidazole
- Life expectancy less than 12 months
- Age less than 18 or greater than 75 years of age
- History of esophageal or gastric motility disorders.
We found this trial at
1
site
Burlington, Vermont 05405
Principal Investigator: Peter L Moses, MD
Phone: 802-656-9094
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