Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
NCT03545386

Fecal Microbiota Transplantation for Pouchitis

Led by McMaster University · Updated on 2024-11-20

34

Participants Needed

1

Research Sites

336 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Fecal Microbiota Transplantation for Pouchitis

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 or over
  • Active pouchitis defined as PDAI of 7-18 points
  • Females of childbearing potential must be willing and able to use acceptable contraception as per Health Canada guidance
Not Eligible

You will not qualify if you...

  • Participating in another clinical trial
  • Unable to give informed consent
  • Severe comorbid medical illness
  • Concomitant Clostridium difficile infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

McMaster University

Hamilton, Ontario, Canada, L8S4K1

Actively Recruiting

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Research Team

N

Neeraj Narula

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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