Fecal Microbiome Transplant
Key facts
- Where
- Philadelphia, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 21 years old?
Source: NCT02636517, who can take part
Where in United States
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Judith Kelsen
- Trial code
- NCT02636517
- Record updated
- 15 April 2026
- Original description
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD)Read full original descriptionShow less
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: 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: Adverse event attributable to a previous FMT; Patients who are on supraphysiologic doses of corticosteroids; Recipients with a history of severe (anaphylactic) food allergy; Any other condition for which the treating physician thinks the treatment may pose a health risk; Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS); Patients <3 years old; 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 other co-morbid intestinal infectious processes; Patients with severe IBD; Ongoing/anticipated antibiotic use for non-CDI indication; Predicted death within time period of follow-up.