Fecal microbiota transplantation for pouchitis treatment
Randomized Trial of Fecal Microbiota Transplantation Versus Placebo for the Induction of Remission in Patients With Active Pouchitis
This study is testing if a new treatment using fecal microbiota transplantation can help people with pouchitis feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT03545386 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of fecal microbiota transplantation (FMT) in increasing remission rates for patients suffering from active pouchitis, a common complication following ileal-pouch anal anastomosis in ulcerative colitis patients. Conducted at McMaster University, the study is a randomized double-blind placebo-controlled trial where participants will receive FMT once weekly for six weeks. The trial aims to compare the outcomes of FMT against a placebo to determine its potential benefits in managing pouchitis. The study addresses the limitations of current antibiotic treatments, which can lead to adverse effects and antibiotic resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with active pouchitis as defined by a PDAI score of 7-18.
Not a fit: Patients with severe comorbid medical illnesses or those currently experiencing a Clostridium difficile infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients with pouchitis, potentially reducing reliance on antibiotics.
How similar studies have performed: Previous studies have shown promise for fecal microbiota transplantation in treating various gastrointestinal disorders, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 or over 2. Active pouchitis defined as PDAI of 7-18 points 3. Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance Exclusion Criteria: 1. Participating in another clinical trial 2. Unable to give informed consent 3. Severe comorbid medical illness 4. Concomitant Clostridium difficile infection
Where this trial is running
Hamilton, Ontario
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Neeraj Narula
- Email: narulan@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.