Fecal Microbiome Transplant

Study Overview
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Brief Summary
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Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD) The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.

Official Title
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Fecal Microbiome Transplant in Pediatric C. Difficile

Conditions
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Clostridium Difficile, Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
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* Biological: Fecal Microbiota Transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol. Age ≥ 3 years old. Recurrent C. difficile or Moderate to Severe C. difficile. Satisfactory completion of the medical interview and physical exam conducted by a study team member Participants must be between 3 and 21 years of age (inclusive) Signed informed consent form, and assent (if applicable) Exclusion Criteria: Patients <3 years old Patients with other co-morbid intestinal infectious processes Recipients with a history of severe (anaphylactic) food allergy If female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the FMT procedure. Patients who are pregnant will not be enrolled. Patients with severe IBD. Ongoing/anticipated antibiotic use for non-CDI indication Adverse event attributable to a previous FMT Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS) Any other condition for which the treating physician thinks the treatment may pose a health risk Predicted death within time period of follow-up Patients who are on supraphysiologic doses of corticosteroids

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: C. Difficile without IBD<br>Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile | Biological: Fecal Microbiota Transplant<br>* Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug<br>|
| Other: C. Difficile with IBD<br>Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease | Biological: Fecal Microbiota Transplant<br>* Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with a recurrence of C. difficile (CDI) | The hypothesis is that FMT will be an effective therapy for patients with IBD and CDI, resulting in resolution of symptoms as compared to historical controls on antibiotic therapy. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota transplant