Fecal Microbiome Transplant

Ulcerative Colitis Clinical Trial

Official title:

Fecal Microbiome Transplant in Pediatric C. Difficile

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02636517
• Other study ID #: 13-010531
• Status: Recruiting
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital of Philadelphia
• Contact: Judith Kelsen, MD
• Phone: 267-426-6822
• Email: kelsen[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Biological:
• Fecal Microbiota Transplant
Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Judith Kelsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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