Recruiting
Phase 1

Fecal Microbiota Transplantation

Sponsor:

McMaster Children's Hospital

Code:

NCT05967871

Conditions

Small Intestinal Bacterial Overgrowth

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota Transplant

Study Details

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 (SIBO).

Conditions

Small Intestinal Bacterial Overgrowth

Study ID

NCT05967871

Start date

Mar 11, 2024

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fecal Microbiota Transpant

Participants will receive a Fecal Microbiota transplant Infusion via participants' existing enteral feeding tubes or via elective upper endoscopy (with infusion into the duodenum). Most patients with SBS at MCH and HSC have an existing enteral feeding tube (gastrostomy or jejunostomy tube).

Interventions

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.

Primary outcome measure

  • Change in Clinical Symptoms (pre/post fecal microbiota transplant) [ Time Frame: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration. ]
  • Rate of Clinical Remission (post fecal microbiota transplant) [ Time Frame: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration. ]
  • Urine Metabolomics Analysis [ Time Frame: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration. ]
  • Change in Microbiome Composition, Function (pre/post fecal microbiota transplant) [ Time Frame: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration. ]
  • Change in Breath Test Results (pre/post fecal microbiota transplant) [ Time Frame: Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration. ]
  • Bloodwork [ Time Frame: Baseline and Week 8 (post-FMT) ]

Central Contacts and Locations

Central contacts

Fariha Chowdhury, BASc, MSc, PhD(c)

647-787-8297chowdf1@mcmaster.ca

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

905-521-2100pain@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Nikhil Pai, MD

905-521-2100pailab@mcmaster.ca

More Information

Sponsor

McMaster Children's Hospital

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster Children's Hospital on 2025-08-21.