Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

Status unconfirmed · Early Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis, Active Moderate

In brief

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.

Key facts

Study ID

NCT02390726

Run by

University of Vermont

People needed

20

Starts

2015-12-01

Expected to finish

2018-09-01

Last updated by the study team

2018-07-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The University of Vermont Medical Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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