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FMT for Postop Crohn's Disease

NCT05248191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

BIOLOGICAL

Capsule fecal microbiota material (cap-FMT)

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.

BIOLOGICAL

Colonoscopic fecal microbiota material (colo-FMT)

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

Sponsors & Collaborators

Principal Investigators

  • Byron Vaughn, MD, MS · University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2023-12-25
Completion
2024-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248191 on ClinicalTrials.gov