Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small 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
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
Treatments tested in this trial
- Fecal Microbiota Transplant
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
McMaster Children's Hospital
Lead sponsor
Hamilton Health Sciences Corporation
Sponsor institution
The Hospital for Sick Children
Collaborator
Source ClinicalTrials.gov