Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

NCT ID: NCT04968951

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-10
• Study Completion Date: 2022-08-22

Brief Summary

The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors. Donors will be specifically screened for Fusobacterium and Sutterella species as well as for global diversity. It is unknown if treatment with antibiotics before FMT improves the engraftment and/or efficacy of FMT in UC, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before FMT therapy. The research team enroll patients from The Susan and Leonard Feinstein IBD Center and our established early diagnosis clinic at Mount Sinai Hospital (MSH).

Detailed Description

This is an open-label two arm pilot study to measure the safety, microbiological and clinical impacts of FMT in patients with ulcerative colitis. The researchers will prospectively enroll 16 UC patients (up to 20 subjects accounting for subjects dropping out) with moderate-severe disease from one tertiary care referral center. The overall objective of the study is to collect robust clinical data and create a tissue repository including blood, stool and biopsies to understand the safety, efficacy and microbial changes FMT has on UC patients. The central hypothesis is that pre-defined oral capsule administered FMT is safe and effective for the treatment of UC.

Objectives: To determine the tolerability, feasibility, and safety of using fecal microbiota transplantation orally as an induction agent for patients with ulcerative colitis. To determine whether fecal microbiota transplantation (FMT) delivered via oral capsules can induce clinical remission in patients with mild to moderate ulcerative colitis. Assess whether pretreatment with antibiotics improves engraftment and efficacy of FMT in UC. To characterize the impact of orally administered FMT on the microbiota of patients with ulcerative colitis, particularly those changes associated with response or lack of response.

Study Outcomes: Clinical remission at Week 8, defined as: Steroid-free clinical remission (Total Mayo less 2) and Endoscopic remission (Mayo endoscopic subscore 0 or 1)

Conditions

Ulcerative Colitis; FMT; Fecal Microbiota Transplant

Study Design

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

Study Groups

FMT with Antibiotics

Participants will receive antibiotics before receiving Fecal Microbiota Transplantation

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

Antibiotic treatment - 125 mg every 6 hrs for 5 days

Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

Encapsulated biologically active human fecal material (donor stool) is provided in capsule form. The fecal material is homogenized with sterile saline, then pelleted and re-suspended in sterile saline/40% glycerol. Participants will receive 15 FMT capsules per day for 3 consecutive days. Capsule are to be swallowed under direct supervision.

Metronidazole

Intervention Type: DRUG

Antibiotic treatment - 250 mg every 6 hrs for 5 days

FMT with placebo

Participants will receive placebo before receiving Fecal Microbiota Transplantation

Group Type: PLACEBO_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

Encapsulated biologically active human fecal material (donor stool) is provided in capsule form. The fecal material is homogenized with sterile saline, then pelleted and re-suspended in sterile saline/40% glycerol. Participants will receive 15 FMT capsules per day for 3 consecutive days. Capsule are to be swallowed under direct supervision.

Placebo

Intervention Type: DRUG

Placebo treatment

Interventions

Vancomycin

Antibiotic treatment - 125 mg every 6 hrs for 5 days

Intervention Type: DRUG

Fecal Microbiota Transplantation

Encapsulated biologically active human fecal material (donor stool) is provided in capsule form. The fecal material is homogenized with sterile saline, then pelleted and re-suspended in sterile saline/40% glycerol. Participants will receive 15 FMT capsules per day for 3 consecutive days. Capsule are to be swallowed under direct supervision.

Intervention Type: BIOLOGICAL

Metronidazole

Antibiotic treatment - 250 mg every 6 hrs for 5 days

Intervention Type: DRUG

Placebo

Placebo treatment

Intervention Type: DRUG

Other Intervention Names

Flagyl; FMT

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 to 75 with UC, with initial diagnosis of UC >3 months prior to time of study enrollment visit
• Partial Mayo score of 4-10 with endoscopic subscore ≥2 on flexible sigmoidoscopy
• Permissible UC medications include oral or rectal administered mesalamines
• Corticosteroids must be discontinued at least 4 weeks before enrollment
• Documented negative C. difficile and GI PCR for enteric pathogens (BioFire) testing before commencement of fecal microbiota transplantation
• Previous documentation of ulcerative colitis based on colonoscopy/flexible sigmoidoscopy with compatible histology

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

Sponsors

Ari M Grinspan

OTHER

Sponsor Role: lead

Responsible Party

Ari M Grinspan

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ari Grinspan, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 18-1464

Identifier Type: -

Identifier Source: org_study_id