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Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

RecruitingNAAges 2 Years - 16 YearsAllTongji Hospital
NCT05321758 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

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📋 Eligibility rules (as published)
Inclusion Criteria: age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \>10 and ≤40, and SES-CD of \>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy Exclusion Criteria: patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
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What it tests

  • Fecal Microbiota Transplantation
  • Immunosuppressive Agents
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Where

1 site
Tongji Hospital
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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