NCT05248191CompletedPhase 1
FMT for Postop Crohn's Disease
Fecal Microbiota Transplant for Postoperative Crohn's Disease
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 9 Feb 2022
- Start date
- Apr 2022
- Primary completion date
- Dec 2023
- Lead sponsor
- University of Minnesota
- Diseases
- Crohn's disease
- NCT number
- NCT05248191
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 23
- From Apr 2022 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic therapy within 15 days
- Probiotic therapy within 15 days
- Anticipated surgical procedure over study period
Other illness
- Severe food allergy
- Diagnosis of end stage liver disease or cirrhosis
Lab values
- Absolute neutrophil count \< 500 cell / uL
Other
- Adenomatous polyps that have not been removed
- Anticipated antibiotic use over the study period
- Subtotal or total colectomy
- Current ostomy (ileostomy or colonoscopy)
- Pregnancy
- Life expectancy \< 6 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
Related publications
- Colonoscopic and oral microbiota transplant therapy yield similar stool and neoterminal ileal engraftment profiles in a single-blind pilot randomized trial.Inflamm Bowel Dis · 2026 · PMID 42334201
This page is information, not medical advice. Discuss any trial with your doctor.