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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
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
729 Previous Clinical Trials
8,470,053 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking high doses of steroids.I have been diagnosed with Inflammatory Bowel Disease through tests.I have had C. difficile infection more than once or it is severe.I am between 3 and 21 years old.I am under 3 years old.I have another infection in my intestines.I am not pregnant and will take a pregnancy test if required.I have severe inflammatory bowel disease.I am currently taking or will take antibiotics for reasons other than C. diff infection.I have had side effects from a previous fecal transplant.I am at least 3 years old.
Research Study Groups:
This trial has the following groups:- Group 1: C. Difficile without IBD
- Group 2: C. Difficile with IBD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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