Fecal Microbiome Transplant

NCT ID: NCT02636517

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C. Difficile without IBD

Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile

Group Type: OTHER

Fecal Microbiota Transplant

Intervention Type: BIOLOGICAL

Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

C. Difficile with IBD

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

Group Type: OTHER

Fecal Microbiota Transplant

Intervention Type: BIOLOGICAL

Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Interventions

Fecal Microbiota Transplant

Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Judith Kelsen

OTHER

Sponsor Role: lead

Responsible Party

Judith Kelsen

Attending Physician - CHCA

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Judith Kelsen, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

13-010531

Identifier Type: -

Identifier Source: org_study_id