NCT05248191

FMT for Postop Crohn's Disease

Fecal Microbiota Transplant for Postoperative Crohn's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-04-20
• Primary completion: 2023-12-25
• Completion: 2024-05-16
• First posted: 2022-02-21
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study