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

NCT05967871 | Recruiting Phase 1

• 1 other identifier: 16581
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (6)

• Change in Clinical Symptoms (pre/post fecal microbiota transplant)

  SIBO Clinical Symptom Scores will be measured using the PedsQL Gastrointestinal Symptoms Scale. This validated instrument has strong age-specific test-retest properties and has been used for functional GI disorders, which have symptoms that strongly overlap with SIBO. Participants will also report symptoms using a Likert scale (Izumo scale). Results of both will be compared.

  Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

• Rate of Clinical Remission (post fecal microbiota transplant)

  Absence of SIBO symptoms

  Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

• Urine Metabolomics Analysis

  Collected urine will be assessed by multisegment injection-capillary electrophoresis-mass spectrometry (MSI-CE-MS), using previously described protocols. This technique will offer additional data on microbiome functional changes. Samples will be measured centrally through the Britz-McKibbin laboratory (PBM). Urine metabolomics outcomes are exploratory.

  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)

  Stool will be collected for microbiome 16S rRNA and shotgun metagenomic sequencing. Samples will be obtained from either stool (per rectum), or distal ostomy outputs (ostomy in continuity with proximal bowel). All samples will be sequenced centrally through the McMaster Genomics Centre (MGC). Samples will be stored in -80 freezers. Participants unable to bring stool samples to MCH or HSC will receive funding support for temperature-controlled courier services from home. Costs of microbiome analyses will be partially subsidized by collaborators (MS).

  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)

  Lactulose breath test

  Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

• Bloodwork

  Bloodwork will include complete blood count (CBC), C-reactive protein (CRP), ferritin, folic acid, alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), serum cytokine profiles (including IL-2, IL-6, IL10, IL-18, TNF) and serum bile acids. Routine institutional testing protocols will be followed at MCH and HSC. Bloodwork outcomes are exploratory. Data will support the development of primary and secondary objectives for future studies.

  Baseline and Week 8 (post-FMT)

Secondary Outcomes (3)

• Monthly Rate of Recruitment

  30 weeks

• Adverse Events

  30 Weeks

• Blood, stool specimens, breath tests, clinical symptom scores

  30 Weeks

Study Arms (1)

Fecal Microbiota Transpant

EXPERIMENTAL

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).

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

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.

Fecal Microbiota Transpant

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• McMaster Children's Hospital: lead
• The Hospital for Sick Children: collaborator

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1X8, Canada

NOT YET RECRUITING

Related Publications (26)

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Related Links

• US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Published 2017.

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Nikhil Pai, MD

  McMaster Children's Hospital (McMater University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fariha Chowdhury, BASc, MSc, PhD(c)

CONTACT

647-787-8297; chowdf1@mcmaster.ca

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

CONTACT

905-521-2100; pain@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Pediatric Gastroenterology & Nutrition

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: March 11, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified individual participant data (IPD) and supporting documentation (such as the study protocol and statistical analysis plan) will be available beginning 12 months after publication of the primary results. Data will remain available for at least 5 years thereafter.
• Access Criteria: Access will be provided to qualified researchers from academic, non-profit, or health system organizations for scientifically sound secondary analyses. Industry investigators may also request access; such requests will be considered on a case-by-case basis and granted only at the discretion of the study investigators. All data will be shared in de-identified form through a secure platform or under a data use agreement that prohibits re-identification and restricts use to the approved research purpose.

Locations

CA (2)