Fecal microbiota transplantation for children with Crohn's disease

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 aims to evaluate the safety and effectiveness of fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) in children aged 2-16 years suffering from refractory Crohn's disease. The approach involves administering multiple courses of FMT alongside standard therapy, with the goal of improving gut health and managing symptoms. Participants will receive FMT 1-2 times per course, with maintenance treatments every three months, while gradually reducing conventional drug therapy. The study focuses on children who have not responded to standard treatments such as steroids and immunomodulators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) \>10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) \> 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)

Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Biao Zou, doctor
• Email: 464021552@qq.com
• Phone: 027-83663594

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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.