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Search / Trial NCT05967871

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.

Locations

Hamilton, Ontario, Canada

Patients applied

0 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