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Microbiome Therapy

Fecal Microbiota Transplant for Clostridium Difficile and IBD

Phase 1
Recruiting
Led By Judith Kelsen, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol
Recurrent C. difficile or Moderate to Severe C. difficile
Must not have
Patients who are on supraphysiologic doses of corticosteroids
Patients <3 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of Fecal Microbiota Transplants (FMT) in children with recurrent C. Difficile infections, with or without Inflammatory Bowel Disease (IBD). 454 pyrosequencing will be used to study the gut microbiota before and after transplantation.

Who is the study for?
This trial is for kids and young adults aged 3-21 with recurrent C. difficile or moderate to severe cases, who may also have Inflammatory Bowel Disease (IBD). They must pass a medical interview and physical exam, not be pregnant if female of childbearing age, and not have other intestinal infections or allergies to certain safe ingredients.
What is being tested?
The study tests Fecal Microbiota Transplant (FMT) in children with C. difficile, observing its safety and effectiveness alone or when combined with IBD. It also examines changes in gut bacteria through advanced sequencing before and after the transplant.
What are the potential side effects?
While specific side effects are not listed here, potential risks could include discomfort at the transplant site, infection from transferred material despite screening processes, allergic reactions or unintended impacts on gut microbiota.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Inflammatory Bowel Disease through tests.
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I have had C. difficile infection more than once or it is severe.
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I am between 3 and 21 years old.
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I am at least 3 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking high doses of steroids.
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I am under 3 years old.
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I have another infection in my intestines.
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I am not pregnant and will take a pregnancy test if required.
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I have severe inflammatory bowel disease.
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I have had side effects from a previous fecal transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with a recurrence of C. difficile (CDI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: C. Difficile without IBDExperimental Treatment1 Intervention
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
Group II: C. Difficile with IBDExperimental Treatment1 Intervention
Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplant
2021
Completed Phase 4
~190

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,784 Total Patients Enrolled
1 Trials studying Clostridium Difficile
412 Patients Enrolled for Clostridium Difficile
Judith KelsenLead Sponsor
Judith Kelsen, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

Media Library

Fecal Microbiota Transplant (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02636517 — Phase 1
Clostridium Difficile Research Study Groups: C. Difficile without IBD, C. Difficile with IBD
Clostridium Difficile Clinical Trial 2023: Fecal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT02636517 — Phase 1
Fecal Microbiota Transplant (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02636517 — Phase 1
~25 spots leftby Dec 2025
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