Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth
Launched by MCMASTER CHILDREN'S HOSPITAL · Jul 22, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a treatment called Fecal Microbiota Transplantation (FMT) for children and teenagers with a condition known as Small Intestinal Bacterial Overgrowth (SIBO). SIBO happens when there are too many bacteria in the small intestine, which can cause various digestive problems. The goal of this study is to see if this new treatment is safe and effective for young patients diagnosed with SIBO.
To participate in this trial, children must be between 3 and 18 years old and have been diagnosed with SIBO through a specific test called a lactose breath test. They should also stop using antibiotics for at least a week before the treatment. Participants will not be able to start any new treatments for eight weeks unless it's necessary for their health. This study is currently recruiting, and it aims to help improve treatment options for young people suffering from SIBO.
Gender
ALL
Eligibility criteria
- 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
About Mcmaster Children's Hospital
McMaster Children’s Hospital is a leading pediatric healthcare institution dedicated to advancing child health through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital focuses on improving treatments and outcomes for children with various medical conditions. Leveraging its multidisciplinary expertise and state-of-the-art facilities, McMaster Children’s Hospital collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical research that adheres to the highest ethical standards. Committed to fostering a culture of inquiry and discovery, the hospital aims to translate research findings into practical applications that enhance the quality of care for pediatric patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hamilton, Ontario, Canada
Patients applied
Trial Officials
Nikhil Pai, MD
Principal Investigator
McMaster University | McMaster Children's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported