Fecal Microbiota Transplant for Small Intestinal Bacterial Overgrowth
What You Need to Know Before You Apply
What is the purpose of 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).
Will I have to stop taking my current medications?
You will need to stop taking antibiotics at least 1 week before the trial starts. You cannot start any new treatments, including antibiotics, probiotics, or antacids, until Week 8 unless it's necessary for your health.
Is fecal microbiota transplantation (FMT) safe for humans?
FMT is generally considered safe and well-tolerated, even in high-risk patients, with most short-term risks being mild and related to delivery methods. However, long-term safety data is limited, and serious adverse events have been associated with inadequate screening for multi-drug resistant organisms in some cases.12345
How is Fecal Microbiota Transplant (FMT) different from other treatments for Small Intestinal Bacterial Overgrowth?
FMT is unique because it involves transferring healthy donor feces into a patient's gut to restore a balanced microbiome, unlike traditional treatments that may use antibiotics to kill bacteria. This approach aims to directly modify the gut environment, potentially offering a novel way to address the root cause of bacterial overgrowth.678910
What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Small Intestinal Bacterial Overgrowth?
Who Is on the Research Team?
Nikhil Pai, MD
Principal Investigator
McMaster University | McMaster Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children and teenagers aged 3-18 who have been diagnosed with Small Intestinal Bacterial Overgrowth (SIBO) confirmed by a lactose breath test. Participants must show symptoms of SIBO and agree to stop taking antibiotics at least one week before the Fecal Microbiota Transplant (FMT).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single Fecal Microbiota Transplant (FMT) infusion via enteral feeding tubes or elective upper endoscopy
Short-term Follow-up
Participants are monitored for clinical efficacy and safety, with outcomes measured at one and four weeks post-FMT
Long-term Follow-up
Participants are monitored for long-term clinical efficacy, including durability of remission and recurrence of symptoms, with outcomes measured at eight weeks post-FMT
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbiota Transplant
Fecal Microbiota Transplant is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster Children's Hospital
Lead Sponsor
The Hospital for Sick Children
Collaborator