FMT for Postop Crohn's Disease

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Ileal-associated microbiota engraftment

Time frame: 8 weeks

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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Fecal Microbiota Transplant for Postoperative Crohn's Disease

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Feb 21, 2022
Registry last updated: Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed