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Microbiota Therapy

Fecal Microbiota Transplant for Small Intestinal Bacterial Overgrowth

Phase 1

Recruiting

Led By Nikhil Pai, MD

Research Sponsored by McMaster Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new treatment using Fecal Microbiota Transplantation for children with small intestinal bacterial overgrowth to see if it is safe and effective."

Who is the study for?

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).

What is being tested?

The study is testing the feasibility and effectiveness of a new treatment protocol using Fecal Microbiota Transplant (FMT) to manage pediatric SIBO.

What are the potential side effects?

Potential side effects are not explicitly listed, but may include discomfort, bloating, changes in bowel habits or allergic reactions related to the transplant procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-fecal microbiota transplant), one-, four-, and eight-weeks post-fecal microbiota transplant administration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bloodwork

Change in Breath Test Results (pre/post fecal microbiota transplant)

Change in Clinical Symptoms (pre/post fecal microbiota transplant)

+3 more

Secondary study objectives

Adverse Events

Blood, stool specimens, breath tests, clinical symptom scores

Monthly Rate of Recruitment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fecal Microbiota TranspantExperimental Treatment1 Intervention

Participants will receive a Fecal Microbiota transplant Infusion via participants' existing enteral feeding tubes or via elective upper endoscopy (with infusion into the duodenum). Most patients with SBS at MCH and HSC have an existing enteral feeding tube (gastrostomy or jejunostomy tube).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplant

2021

Completed Phase 4

~190

Do I qualify?Apply below to find out