Actively Recruiting

Phase 1
Age: 3Years - 18Years
All Genders
NCT05967871

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

146 weeks

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

Official 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 symptoms of SIBO
Not Eligible

You will not qualify if you...

  • Participants cannot start new treatments (antibiotics, probiotics, antacids, antimotility) until Week 8 unless clinically needed
  • Children under 3 years old are excluded to avoid microbial transmission concerns and ensure ability to perform LBT
  • Participants must be referred by their primary or subspecialty physician

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)

CONTACT

N

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

CONTACT

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