Status:
RECRUITING
Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth
Lead Sponsor:
McMaster Children's Hospital
Collaborating Sponsors:
The Hospital for Sick Children
Conditions:
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
3-18 years
Phase:
PHASE1
Brief 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 (SI...
Detailed Description
BACKGROUND AND RATIONALE Fecal microbiota transplant (FMT) is an established treatment for the management of recurrent Clostridioides difficile (CDI) infection in children and adults, including childr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05967871
Start Date
March 11 2024
End Date
December 31 2026
Last Update
August 21 2025
Active Locations (2)
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1
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
2
Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G 1X8