RecruitingPhase 1

Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth

Canada20 participantsStarted 2024-03-11

Plain-language summary

The objective of the study is to assess feasibility, and clinical efficacy of a novel Fecal Microbiota Transplantation protocol for the treatment of pediatric small intestinal bacterial overgrowth (SIBO).

Who can participate

Age range3 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Clinical Symptoms (pre/post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Rate of Clinical Remission (post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Urine Metabolomics Analysis

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Change in Microbiome Composition, Function (pre/post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Change in Breath Test Results (pre/post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Bloodwork

Timeframe: Baseline and Week 8 (post-FMT)

Trial details

NCT IDNCT05967871

SponsorMcMaster Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Fariha Chowdhury, BASc, MSc, PhD(c)

647-787-8297 chowdf1@mcmaster.ca

View on ClinicalTrials.gov More Small Intestinal Bacterial Overgrowth trials

Who can participate

Age range3 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Clinical Symptoms (pre/post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Rate of Clinical Remission (post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Urine Metabolomics Analysis

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Change in Microbiome Composition, Function (pre/post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Change in Breath Test Results (pre/post fecal microbiota transplant)

Timeframe: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Bloodwork

Timeframe: Baseline and Week 8 (post-FMT)