Health TrialsbyHealthPanel

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

ConditionSmall Intestinal Bacterial Overgrowth
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-18
SponsorMcMaster Children's Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fecal Microbiota Transplant

    Biological/Vaccine

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Fecal Microbiota TranspantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.
2

Rate of Clinical Remission (post fecal microbiota transplant)

Absence of SIBO symptoms

Time frame
Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.
3

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.

Time frame
Baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.
4

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).

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

Secondary outcomes

1

Monthly Rate of Recruitment

Recruitment/month. ≥2 participants/month.

Time frame
30 weeks
2

Adverse Events

Adverse and serious events will be recorded using the Common Terminology Criteria for Adverse Events. \<10% participants

Time frame
30 Weeks
3

Blood, stool specimens, breath tests, clinical symptom scores

Participant provides all required blood, stool, lactulose breath tests, and symptom scores per protocol. \>80% participants

Time frame
30 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster Children's Hospital

Lead sponsor

Hamilton Health Sciences Corporation

Sponsor institution

The Hospital for Sick Children

Collaborator

Source ClinicalTrials.gov
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