Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

Recruiting now · Not applicable

Conditions studied: Ulcerative Colitis

In brief

This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC

Key facts

Study ID

NCT05679622

Run by

Biao Zou

People needed

30

Starts

2022-12-01

Expected to finish

2026-06-30

Last updated by the study team

2026-07-10

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Tongji Hospital — Wuhan, China (enrolling)

Full record on ClinicalTrials.gov

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