MedTrace Logo

Fecal Microbiota Transplantation for Pouchitis

NCT03545386 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-11-20

No results posted yet for this study

Summary

This is a randomized double-blind placebo controlled trial involving a single centre (McMaster University) recruiting patients from Hamilton, ON and the surrounding regions, to evaluate whether fecal microbiota transplantation once weekly for six weeks increases the remission rate compared to placebo in patients with active pouchitis.

Conditions

  • Pouchitis

Interventions

OTHER

Fecal microbiota transplantation

Stool from healthy donor administered via enema

OTHER

Placebos

Saline with food coloring administered via enema

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2025-07-31
Completion
2025-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT03545386 on ClinicalTrials.gov