Fecal microbiota transplantation for children with ulcerative colitis

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 efficacy and safety of fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) in treating pediatric patients with refractory ulcerative colitis (UC) and as a first-line therapy for active UC. The trial includes two groups: one for children who have not responded to conventional treatments and another for those newly diagnosed with mild-to-moderate UC. Participants will receive FMT and PEN while continuing standard therapy, with the aim of gradually reducing conventional drug therapy. The study seeks to determine if this combined approach can improve clinical outcomes in these young patients.

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; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy

Exclusion Criteria:

Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; 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, China Recruiting

Study contacts

• Study coordinator: Biao Zou
• Email: 464021552@qq.com
• Phone: +8685726753

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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.