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Microbiota Therapy

Fecal Microbiota Transpant 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

Study 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).Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bloodwork

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

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

+3 more

Secondary outcome measures

Adverse Events

Blood, stool specimens, breath tests, clinical symptom scores

Monthly Rate of Recruitment

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

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER

690 Previous Clinical Trials

6,945,458 Total Patients Enrolled

McMaster Children's HospitalLead Sponsor

38 Previous Clinical Trials

17,305 Total Patients Enrolled

Nikhil Pai, MDPrincipal InvestigatorMcMaster University | McMaster Children's Hospital

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals actively engaged in this medical study?

"Affirmed. Details found on clinicaltrials.gov reveal that this ongoing medical investigation is actively enrolling participants. The trial's initial posting was recorded on March 11, 2024, with the most recent update dated March 13, 2024. Enrollment aims to include a total of 20 individuals from a single designated site."

Answered by AI

Which individuals meet the criteria for inclusion in this research study?

"The clinical trial seeks to recruit 20 individuals aged between 3 and 18 who have small intestinal bacterial overgrowth (SIBO). Essential requirements include a confirmed SIBO diagnosis via lactose breath test, manifestation of SIBO symptoms, age falling within the range of 3-18 years old, and patients must discontinue antibiotics for at least one week before fecal microbiota transplantation (FMT)."

Answered by AI

Is there an age limit for participants over 70 years old to be included in this research study?

"This research invites participation from individuals aged above 36 months but below 18 years."

Answered by AI

Has the FDA provided approval for Fecal Microbiota Transplantation as a medical procedure?

"Our team at Power has assessed the safety of Fecal Microbiota Transplant to be a 1 on our scale. This rating reflects that this is a Phase 1 trial with limited evidence supporting both its safety and effectiveness."

Answered by AI

Are new participants currently being sought for this medical study?

"Yes, the details on clinicaltrials.gov indicate that this investigation is presently seeking participants. The trial was first listed on 3/11/2024 and has been most recently revised on 3/13/2024. This study aims to enroll 20 individuals at a single site."

Answered by AI

Who else is applying?

What site did they apply to?

McMaster Children's Hospital

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

My Daughter, Emma Hartz, 16, has anorexia nervosa - restrictive type which was preceded by SIBO. based on current literature, addressing the microbiome may serve to also allay her AN-R symptoms. for our family, this is far more dire than simply GI issues. kevin hartz (father).

PatientReceived 2+ prior treatments

Recent research and studies

MicrobiomeJournal

Microbiota Transfer Therapy Alters Gut Ecosystem and Improves Gastrointestinal and Autism Symptoms: An Open-label Study

Kang, Dae-Wook, James B. Adams, Ann C. Gregory, Thomas Borody, Lauren Chittick, Alessio Fasano, Alexander Khoruts, et al.. 2017. “Microbiota Transfer Therapy Alters Gut Ecosystem and Improves Gastrointestinal and Autism Symptoms: An Open-label Study”. Microbiome. Springer Science and Business Media LLC. doi:10.1186/s40168-016-0225-7.

BMJ OpenJournal

Protocol for a Randomised, Placebo-controlled Pilot Study for Assessing Feasibility and Efficacy of Faecal Microbiota Transplantation in a Paediatric Ulcerative Colitis Population: Pedifetch Trial

Pai, Nikhil, and Jelena Popov. 2017. “Protocol for a Randomised, Placebo-controlled Pilot Study for Assessing Feasibility and Efficacy of Faecal Microbiota Transplantation in a Paediatric Ulcerative Colitis Population: Pedifetch Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2017-016698.

clinicaltrials.govStudy

Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth

Nikhil Pai 2024. "Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05967871.

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