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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of subjects with a recurrence of C. difficile (CDI)

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 3
~170

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
706 Previous Clinical Trials
8,571,190 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

Frequently Asked Questions

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

Is there an opportunity for volunteers to join this research effort?

"This clinical trial, which was initially listed on December 1st 2015 and last updated on April 4th 2022, is not currently seeking applicants. Although this specific study is closed for recruitment, there are 500 other trials actively pursuing participants at the present moment."

Answered by AI

Are there any eligibility criteria I must satisfy in order to participate in this experimental research?

"This latest clinical trial is seeking 250 participants aged between 3 and 21 with inflammatory bowel diseases (IBD). To be considered, entrants must match the following criteria: age of at least three years old; recurrent or moderate to severe C. difficile infection; approval from a study team member after completing a medical interview and physical examination; ages ranging inclusively from 3 to 21 years old."

Answered by AI

Can patients younger than 55 years partake in this trial?

"This research looks to recruit participants aged between 3 and 21. There are 121 studies involving individuals under 18, while those aged over 65 have 390 distinct trials available to them."

Answered by AI
~42 spots leftby Dec 2025