Fecal Microbiome Transplant

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02636517
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clostridium Difficile; Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis	Biological: Fecal Microbiota Transplant	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fecal Microbiome Transplant in Pediatric C. Difficile
• Study Start Date: Dec 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Children's Hospital of Philadelphia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT02636517
• Other Study ID Numbers: 13-010531
• First Posted: Dec 21, 2015
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Children's Hospital of Philadelphia: Fecal Microbiota transplant
• Additional relevant MeSH terms: Crohn Disease; Inflammatory Bowel Diseases

Study Results

No Results Posted as of Apr 12, 2022