Fecal Microbiome Transplant

Judith Kelsen

Status and phase: Invitation-only; Phase 1

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

Treatments: Biological: Fecal Microbiota Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT02636517

13-010531

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 3 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

C. Difficile without IBD

Other group

Description:

Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile

Treatment:

Biological: Fecal Microbiota Transplant

C. Difficile with IBD

Other group

Description:

Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease

Treatment:

Biological: Fecal Microbiota Transplant