NCT07458984

FMT Capsules for rCDI

Fecal Microbiota (FMT) Oral Capsules in the Treatment of Recurrent Clostridioides Difficile Infection

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Double blind RCT study of tretment of recurrent Clostridioides difficile infection by FMT capsules.

Detailed description

The aim of the study is to investigate the efficacy and safety of fecal capsules in the treatment of recurrent Clostridioides difficile infection in a double-blind RCT. The study will also investigate whether stool antigen testing or accurate clinical information on risk factors can identify patients who would benefit most from fecal transplantation. The study will include 76 patients who have had recurrent Clostridioides difficile infection.

Conditions

• Clostridioides Difficile Infection Recurrence
• FMT

Interventions

Type	Name	Description
BIOLOGICAL	Healthy donor stool	Healthy donor stool given by capsules produced by the same method as in Copenhagen University Hospital
BIOLOGICAL	placebo capsule	Copenhagen University Hvidrovre Hospital method for capsule production

Timeline

• Start date: 2026-02-25
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: Finland