Fecal Transplant for Ulcerative Colitis

NCT03948919 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GI-2019-27285
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the engraftment of donor microbiota with active ulcerative colitis (UC) following sequential fecal microbiota transplant (FMT). One key group of bacteria we are following are sulfate reducing bacteria (SRB). We plan to measure the relative abundance of SRB at baseline and after FMT. It is widely unknown if the microbiota in UC is dysfunctional and therefore perpetuates inflammation, or if the ongoing inflammation shapes the microbiota. We aim to determine if we can alter the microbiota in UC towards a healthy, more diverse microbiota resembling the donor using capsule FMT material.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Engraftment of donor microbiota

  Engraftment measured by SourceTracker at baseline to week 12 between FMT arm and placebo arm.

  12 weeks

Secondary Outcomes (4)

• Clinical efficacy of FMT versus placebo

  8 weeks

• Clinical efficacy of low sulfate reducing microbiota

  12 weeks

• Rate of change of sulfate reducing microbiota

  4 weeks

• Serious adverse events

  12 weeks

Study Arms (2)

FMT Treatment

ACTIVE COMPARATOR

Fecal microbiota - 1.0-3.0 x 10\^11 CFU / day (2 capsules per day for 8 weeks).

Drug: Fecal microbiota

Placebo

PLACEBO COMPARATOR

The placebo consists of a mixture of trehalose and crystalline methylcellulose (Avicel) in 6:1 (w/w) ratio that is packaged in size 0 swedish orange capsules, which are then double encapsulated in size 00 natural colored capsules to make them visibly indistinguishable from encapsulated active product. Two capsules taken daily for 8 weeks.

Drug: Placebo

Interventions

Fecal microbiota DRUG

Lyophilized encapsulated fecal microbiota given daily for 8 weeks.

FMT Treatment

Placebo DRUG

Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide consent
• English speaking
• Diagnosis of ulcerative colitis based on typical clinical-histopathic diagnosis
• Diagnosis of ulcerative colitis \> 3 months
• Active disease on endoscopy (endoscopic Mayo subscore ≥ 1)
• Evidence of inflammation extending beyond a minimum of 20cm
• Any ongoing ulcerative colitis therapy must be at stable doses for 4 weeks prior to study and remain stable over the course of the study

You may not qualify if:

• Extensive bowel resection
• Presence of ileostomy or colostomy
• Suspicion of ischemic colitis, radiation colitis or microscopic colitis
• Diagnosis of Crohn's disease
• Diagnosis of per-anal fistula or abscess
• Adenomatous polyps that have not been removed
• Use of pre or probiotics within 30 days of randomization
• Pregnancy
• Severe food allergies
• End stage liver disease or cirrhosis
• An absolute neutrophil count \< 500 cell/µL
• Life expectancy \< 6 months

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Byron Vaughn, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: May 14, 2019
• Study Start: July 31, 2019
• Primary Completion: November 3, 2023
• Study Completion: January 4, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)