Fecal Microbiome Transplant

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Judith Kelsen
Study ID
NCT02636517
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplant — BIOLOGICAL
    Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug

Study Details

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.

Key Dates

Start date
Dec 31, 2015
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: C. Difficile without IBD
    Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile
  • Other: C. Difficile with IBD
    Fecal Microbiota transplant in pediatric patients with recurrent C. Difficile with Inflammatory Bowel Disease

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Crohn's diseaseUlcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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