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RECRUITING
NCT05967871
PHASE1

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

Sponsor: McMaster Children's Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

3 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-03-11

Completion Date

2026-12-31

Last Updated

2025-08-21

Healthy Volunteers

No

Interventions

BIOLOGICAL

Fecal Microbiota Transplant

Participants will receive approximately 50 grams of human stool/150mL (approximately 107 microbes/mL of suspension) in saline, prepared as per standard collection, preparation, and screening protocols for FMT infusion developed by our institutional stool bank in accordance with recognized standards. Fecal microbiota transplant infused via existing enteral feeding tube or upper elective endoscopy (with infusion into the duodenum) x1.

Locations (2)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada