NCT04746222

Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization

Oral Capsule-administered Faecal Microbiota Transplantation for Intestinal Carbapenemase-producing Enterobacteriaceae Decolonization

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Double-blinded, randomised controlled trial to evaluate the clinical efficacy of a single dose of oral capsule-administered faecal microbiota transplantation (FMT) for carbapenemase-producing Enterobacteriaceae (CPE) intestinal decolonisation compared with placebo. Primary outcome is the proportion of patients successfully decolonised of CPE intestinal carriage at 12 weeks after FMT treatment compared with placebo.

Conditions

• Carbapenem-Resistant Enterobacteriaceae Infection

Interventions

Type	Name	Description
BIOLOGICAL	Oral capsule faecal microbiota transplantation	Single dose of 30 oral capsules containing healthy donor stool from a stool bank
OTHER	Placebo	Single dose of 30 oral placebo capsules

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-01
• Completion: 2023-07-01
• First posted: 2021-02-09
• Last updated: 2021-02-09