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

Recruiting now · Phase 1

Conditions studied: Small Intestinal Bacterial Overgrowth

In brief

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).

Key facts

Study ID

NCT05967871

Run by

McMaster Children's Hospital

People needed

20

Starts

2024-03-11

Expected to finish

2026-12-31

Last updated by the study team

2025-08-21

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• McMaster Children's Hospital — Hamilton, Ontario, Canada (enrolling)
• Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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