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Fecal Microbiome Transplant | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1

Fecal Microbiome Transplant

Fecal Microbiome Transplant in Pediatric C. Difficile

NCT02636517•Judith Kelsen

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

Age

3 - 21 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 1, 2015

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

March 11, 2025

Enrollment

250

ESTIMATED participants

Conditions

Clostridium DifficileInflammatory Bowel DiseaseCrohn's DiseaseUlcerative Colitis

Interventions

Fecal Microbiota Transplant

BIOLOGICAL

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

View study

RECRUITINGPHASE3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452

Clostridium DifficileClostridium Difficile Infections+8 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Fecal Microbiome Transplant

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Impact of Morning Light Therapy in IBD

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)