Fecal Microbiome Transplant

Last updated: March 6, 2025
Sponsor: Judith Kelsen
Overall Status: Active - Enrolling

Phase

1

Condition

Inflammatory Bowel Disease

Gastrointestinal Diseases And Disorders

Crohn's Disease

Treatment

Fecal Microbiota Transplant

Clinical Study ID

NCT02636517
13-010531
  • Ages 3-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of Inflammatory Bowel Disease by colonoscopy, radiographic and clinicmeasures, 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 astudy team member

  5. Participants must be between 3 and 21 years of age (inclusive)

  6. Signed informed consent form, and assent (if applicable)

Exclusion

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 orthose who have already begun menstruating) will be required to have a urinepregnancy test on the day of the FMT procedure. Patients who are pregnant will notbe 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 GenerallyRecognized As Safe (GRAS)

  9. Any other condition for which the treating physician thinks the treatment may pose ahealth risk

  10. Predicted death within time period of follow-up

  11. Patients who are on supraphysiologic doses of corticosteroids

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Fecal Microbiota Transplant
Phase: 1
Study Start date:
December 01, 2015
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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