Using fecal microbiota transplant to treat small intestinal bacterial overgrowth in children
Official title: Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth
Run by McMaster Children's Hospital · NCT05967871 · Data updated 2026-11-12
This study is testing if a new treatment using fecal microbiota transplant can help children with small intestinal bacterial overgrowth feel better instead of relying on antibiotics.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | McMaster Children's Hospital Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | March 11, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 21, 2025 |
| Trial ID | NCT05967871 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 3 to 18 years diagnosed with small intestinal bacterial overgrowth.
✕Probably not a fit
Patients younger than 3 years old or those currently on antibiotics or other specified treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot feasibility study aims to evaluate the safety and clinical efficacy of a novel fecal microbiota transplantation (FMT) protocol specifically for pediatric patients suffering from small intestinal bacterial overgrowth (SIBO). The study will assess the feasibility of administering FMT, including the acceptability to both children and their parents, as well as the ease of administration and sample collection. Participants will be children aged 3 to 18 years who have been diagnosed with SIBO and will discontinue antibiotics prior to the intervention. The study seeks to provide an alternative treatment approach to traditional broad-spectrum antibiotics, which may lead to persistent dysbiosis and other complications.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective solution for managing SIBO in pediatric patients, potentially improving their quality of life.
How similar studies have gone: While fecal microbiota transplantation has been established for other conditions, this specific application for pediatric SIBO is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 3-18 years old * Patients will discontinue antibiotics for at least 1 week prior to FMT * A diagnosis of SIBO established through lactose breath test (LBT), and showing of symptoms of SIBO Exclusion Criteria: * Participants will not be permitted to start any new treatments (including antibiotics, probiotics, antacid treatments, or antimotility treatments) until Week 8, unless clinically indicated * We will exclude participants \<3yo to avoid potential concerns of microbial transmission in young children, and to ensure participants are developmentally able to perform LBT * All potential participants should request a referral through their primary, or subspecialty physician. We would be pleased to help facilitate this contact if needed, provided the appropriate contact information can be sent.
Where it's running
-
McMaster Children's Hospital
Hamilton, Ontario, Canada Recruiting -
Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada Not yet recruiting
Study contacts
- Principal investigator: Nikhil Pai, MD — McMaster Children's Hospital (McMater University)
- Study coordinator: Fariha Chowdhury, BASc, MSc, PhD(c)
- Email: chowdf1@mcmaster.ca
- Phone: 647-787-8297
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.