Fecal Microbiome Transplant

Enrolling by invitation · Phase 1

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

In brief

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.

Key facts

Study ID

NCT02636517

Run by

Judith Kelsen

People needed

250

Starts

2015-12-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-15

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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