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New treatment option for Small Intestinal Bacterial Overgrowth
Official title Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth
ClinicalTrials.gov ID: NCT05967871
What this study is testing
What is Fecal Microbiota Transplant?
Fecal Microbiota Transplant is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small intestinal bacterial overgrowth.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- 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
You likely can't join if
- Participants will not be permitted to start any new treatments (including antibiotics, probiotics, antacid treatments, or antimotility treatments)...
- We will exclude participants \<3yo to avoid potential concerns of microbial transmission in young children, and to ensure participants are...
- All potential participants should request a referral through their primary, or subspecialty physician. We would be pleased to help facilitate this...
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.