Fecal Microbiome Transplant

NCT02636517 | Enrolling By Invitation Phase 1

• 1 other identifier: 13-010531
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

Fecal Microbiota transplant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

C. Difficile without IBD

OTHER

Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile

Biological: Fecal Microbiota Transplant

C. Difficile with IBD

OTHER

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

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

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

C. Difficile with IBD; C. Difficile without IBD

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinic measures, as per standard protocol.
• Age ≥ 3 years old.
• Recurrent C. difficile or Moderate to Severe C. difficile.
• Satisfactory completion of the medical interview and physical exam conducted by a study team member
• Participants must be between 3 and 21 years of age (inclusive)
• Signed informed consent form, and assent (if applicable)

You may not qualify if:

• Patients \<3 years old
• Patients with other co-morbid intestinal infectious processes
• Recipients with a history of severe (anaphylactic) food allergy
• 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.
• Patients with severe IBD.
• Ongoing/anticipated antibiotic use for non-CDI indication
• Adverse event attributable to a previous FMT
• Patients with allergies to sodium chloride or glycerol, both ingredients Generally Recognized As Safe (GRAS)
• Any other condition for which the treating physician thinks the treatment may pose a health risk
• Predicted death within time period of follow-up
• Patients who are on supraphysiologic doses of corticosteroids

Sponsors & Collaborators

• Judith Kelsen: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Judith Kelsen, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician - CHCA

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 21, 2015
• Study Start: December 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)