Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

NCT ID: NCT02390726

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-09-30

Brief Summary

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.

Conditions

Ulcerative Colitis, Active Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Sham FMT and Sham Microbial Maintenance plus standard therapy

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Treatment

FMT and microbial maintenance plus standard therapy

Group Type: EXPERIMENTAL

Fecal Microbiota Transplant

Intervention Type: BIOLOGICAL

Interventions

Fecal Microbiota Transplant

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Peter L. Moses, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter L Moses, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Vermont Medical Center

Locations

The University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

References

Crothers JW, Chu ND, Nguyen LTT, Phillips M, Collins C, Fortner K, Del Rio-Guerra R, Lavoie B, Callas P, Velez M, Cohn A, Elliott RJ, Wong WF, Vo E, Wilcox R, Smith M, Kassam Z, Budd R, Alm EJ, Mawe GM, Moses PL. Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. BMC Gastroenterol. 2021 Jul 8;21(1):281. doi: 10.1186/s12876-021-01856-9.

Reference Type: DERIVED

PMID: 34238227 (View on PubMed)

Other Identifiers

15373

Identifier Type: -

Identifier Source: org_study_id