Clostridium Difficile, Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Fecal Microbiota transplant
Brief summary
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.
Interventions
BIOLOGICALFecal Microbiota Transplant
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
Sponsors
Judith Kelsen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with a recurrence of C. difficile (CDI) | 7 days | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJudith Kelsen, MD
Children's Hospital of Philadelphia
Outcome results
None listed