Actively Recruiting

Phase 1
Age: 3Years - 18Years
All Genders
ID05967871

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

Led by McMaster Children's Hospital · Updated on 2025-08-21

20

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

M

McMaster Children's Hospital

Lead Sponsor

T

The Hospital for Sick Children

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

McMaster Children's Hospital

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

2

Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada, M5G 1X8

Not Yet Recruiting

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Research Team

F

Fariha Chowdhury, BASc, MSc, PhD(c)

N

Nikhil Pai, BSc, MD, CNSC, FRCPC, FAAP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection and Other Conditions in Children: A Joint Position Paper From the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

Zev H Davidovics, Sonia Michail, Maribeth R Nicholson...

https://pubmed.ncbi.nlm.nih.gov/30540704

Protocol for a double-blind, randomised, placebo-controlled pilot study for assessing the feasibility and efficacy of faecal microbiota transplant in a paediatric Crohn's disease population: PediCRaFT Trial.

Nikhil Pai, Jelena Popov, Lee Hill...

https://pubmed.ncbi.nlm.nih.gov/31784432

Results of the First Pilot Randomized Controlled Trial of Fecal Microbiota Transplant In Pediatric Ulcerative Colitis: Lessons, Limitations, and Future Prospects.

Nikhil Pai, Jelena Popov, Lee Hill...

https://pubmed.ncbi.nlm.nih.gov/33961887

Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study.

Dae-Wook Kang, James B Adams, Ann C Gregory...

https://pubmed.ncbi.nlm.nih.gov/28122648

Serial Frozen Fecal Microbiota Transplantation in the Treatment of Chronic Intestinal Pseudo-obstruction: A Preliminary Study.

Lili Gu, Chao Ding, Hongliang Tian...

https://pubmed.ncbi.nlm.nih.gov/27840368

Intestinal Microbial and Metabolic Alterations Following Successful Fecal Microbiota Transplant for D-Lactic Acidosis.

Emily C Bulik-Sullivan, Sayanty Roy, Ryan J Elliott...

https://pubmed.ncbi.nlm.nih.gov/29901551