The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis

CHLA-16-00050

Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double blind, placebo controlled study. The safety and efficacy of the intervention will be closely monitored.

2016-11-01

2023-11-01

2023-11-01

Active (not recruiting)

Early phase I

101

Inclusion Criteria * Age: 7-21 who have been diagnosed with ulcerative colitis * Mild to moderate disease based on PUCAI with a score of 10-64 * Need for colonoscopy Exclusion Criteria * Children who are known to be resistant to steroid therapy, immunomodulators and biologics, or on a steroid dose greater than 0.5 mg/kg/day (maximum 20 mg) * Children with recent dose change of biologics (within 4 weeks), 5-ASA, steroids or immunomodulators (within 4 weeks) * Allergy to or intolerance of mesalamine or 5-ASA products * Any evidence of infectious colitis * Concurrent infections that require anti-microbial therapy (such as abdominal abscess, pneumonia, etc...) * Unable to give informed consent/assent * Have received probiotic preparations ≤ 4 weeks prior to randomization * Pregnancy and breast feeding in patient subjects of childbearing potential * Subjects with significant renal and liver dysfunction (creatinine \> 2 mg/dl and direct bilirubin \> 2 mg/dl), Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed due to conditions other than ulcerative colitis (such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 101, 'type': 'ESTIMATED'}}

2023-11-02