FMT for Postop Crohn's Disease

NCT05248191 | Completed Phase 1 FDA Drug

• 1 other identifier: GI-2022-30546
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery. Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.

Conditions

Crohn Disease

Keywords

Crohn's disease; Ileocecal resection; Fecal microbiota transplant; Intestinal microbiota transplant

Outcome Measures

Primary Outcomes (1)

• Ileal-associated microbiota engraftment

  Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.

  8 weeks

Study Arms (2)

Capsule fecal microbiota material (cap-FMT)

EXPERIMENTAL

Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly.

Biological: Capsule fecal microbiota material (cap-FMT)

Colonoscopic fecal microbiota material (colo-FMT) plus placebo

ACTIVE COMPARATOR

Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly.

Biological: Colonoscopic fecal microbiota material (colo-FMT)

Interventions

Capsule fecal microbiota material (cap-FMT) BIOLOGICAL

Cap-FMT consists of Lyophilized FMT administered at 5 x 10\^11 bacteria per capsule daily for five days, for a total dose of 2.5 x 10\^12 bacteria.

Capsule fecal microbiota material (cap-FMT)

Colonoscopic fecal microbiota material (colo-FMT) BIOLOGICAL

Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10\^12 bacteria as liquid.

Colonoscopic fecal microbiota material (colo-FMT) plus placebo

Eligibility Criteria

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

You may qualify if:

• Able and willing to sign informed consent form
• Age 18 or older
• English speaking
• Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
• Prior ileocecal resection for CD
• Stable medications for 30 days
• Women of reproductive age: Agree to remain abstinent or use effective birth control
• Able and willing to comply with all study procedures

You may not qualify if:

• Antibiotic therapy within 15 days
• Probiotic therapy within 15 days
• Adenomatous polyps that have not been removed
• Anticipated antibiotic use over the study period
• Subtotal or total colectomy
• Current ostomy (ileostomy or colonoscopy)
• Anticipated surgical procedure over study period
• Pregnancy
• Severe food allergy
• Diagnosis of end stage liver disease or cirrhosis
• Absolute neutrophil count \< 500 cell / uL
• 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

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Byron Vaughn, MD, MS

  University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo capsules are indistinguishable from study FMT capsules.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded randomized controlled trial

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: April 20, 2022
• Primary Completion: December 25, 2023
• Study Completion: May 16, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)