Fecal Microbiome Transplant



Status:Recruiting
Conditions:Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Gastrointestinal, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:3 - 21
Updated:12/15/2018
Start Date:December 2015
End Date:December 2023
Contact:Judith Kelsen, MD
Email:kelsen@email.chop.edu
Phone:267-426-6822

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Fecal Microbiome Transplant in Pediatric C. Difficile

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.


Inclusion Criteria:

1. Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic
measures, as per standard protocol.

2. Age ≥ 3 years old.

3. Recurrent C. difficile or Moderate to Severe C. difficile.

4. Satisfactory completion of the medical interview and physical exam conducted by a
study team member

5. Participants must be between 3 and 21 years of age (inclusive)

6. Signed informed consent form, and assent (if applicable)

Exclusion Criteria:

1. Patients <3 years old

2. Patients with other co-morbid intestinal infectious processes

3. Recipients with a history of severe (anaphylactic) food allergy

4. 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.

5. Patients with severe IBD.

6. Ongoing/anticipated antibiotic use for non-CDI indication

7. Adverse event attributable to a previous FMT

8. Patients with allergies to sodium chloride or glycerol, both ingredients Generally
Recognized As Safe (GRAS)

9. Any other condition for which the treating physician thinks the treatment may pose a
health risk

10. Predicted death within time period of follow-up

11. Patients who are on supraphysiologic doses of corticosteroids
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 267-426-6822
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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