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Oral Capsule Faecal Microbiota Transplantation for CPE Decolonization

NCT04746222 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Singapore Clinical Research Institute

    collaborator OTHER

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Oon Tek Ng, MBBS · Tan Tock Seng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2022-10-31
Completion
2023-07-31

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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 NCT04746222 on ClinicalTrials.gov