Fecal Microbiome Transplant

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT02636517
• Date of registration: 16/12/2015
• Prospective Registration: No
• Primary sponsor: Judith Kelsen
• Public title: Fecal Microbiome Transplant
• Scientific title: Fecal Microbiome Transplant in Pediatric C. Difficile
• Date of first enrolment: December 2015
• Target sample size: 250
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02636517
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Judith Kelsen, MD

• Name: Judith Kelsen, MD

• Name: Judith Kelsen, MD
• Affiliation: Children's Hospital of Philadelphia

Key inclusion & exclusion criteria

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



Age minimum: 3 Years
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Clostridium Difficile

Ulcerative Colitis

Crohn's Disease

Intervention(s)

Biological: Fecal Microbiota Transplant

Primary Outcome(s)

Number of subjects with a recurrence of C. difficile (CDI) [Time Frame: 7 days]

Secondary ID(s)

13-010531

Source(s) of Monetary Support

Please refer to primary and secondary sponsors