Fecal Microbiome Transplant

Fecal Microbiome Transplant in Pediatric C. Difficile

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Crohn's Disease; Ulcerative Colitis; Inflammatory Bowel Disease; Clostridium Difficile
• Intervention / Treatment: Biological: Fecal Microbiota Transplant

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: C. Difficile without IBD; Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile	Biological: Fecal Microbiota Transplant; Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
Other: C. Difficile with IBD; Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease	Biological: Fecal Microbiota Transplant; Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with a recurrence of C. difficile (CDI)	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.	7 days

Collaborators and Investigators

• Sponsor: Judith Kelsen
• Investigators: Principal Investigator: Judith Kelsen, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimated): December 21, 2015

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Fecal Microbiota transplant
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Therapeutics; Biological Therapy; Fecal Microbiota Transplantation
• Other Study ID Numbers: 13-010531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO