NCT02636517Enrolling by invitationPhase 1
Fecal Microbiome Transplant
Fecal Microbiome Transplant in Pediatric C. Difficile
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 16 Dec 2015
- Start date
- Dec 2015
- Primary completion date
- Dec 2027
- Lead sponsor
- Judith Kelsen
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT02636517
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 250
- From Dec 2015 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Adverse event attributable to a previous FMT
- Patients who are on supraphysiologic doses of corticosteroids
Other illness
- 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
Lab values
- Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
Age
- 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.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 3 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.