Using fecal microbiota transplantation to treat active Crohn's disease in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and effectiveness of repeated fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease in pediatric patients. Participants aged 2 to 16 years with newly diagnosed mild-to-moderate Crohn's disease will be divided into two groups: one receiving FMT and PEN, and the other receiving PEN with immunosuppressive agents. The study aims to compare the therapeutic effects of these two approaches, with FMT administered through various routes including oral capsules and enemas. All patients will also receive a polymeric diet to support clinical remission.

Why it matters

Who can join: the full rules

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

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Biao Zou, MD
• Email: 464021552@qq.com
• Phone: 15871365900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.