Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis (FMTUC)

University of Vermont

Status and phase

Unknown

Early Phase 1

Conditions

Ulcerative Colitis, Active Moderate

Treatments

Biological: Placebo

Biological: Fecal Microbiota Transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT02390726

15373

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.