RecruitingNot ApplicableNCT05679622

Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)


Sponsor

Biao Zou

Enrollment

30 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 2 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing fecal microbiota transplantation (FMT) — a procedure where healthy donor stool is transferred to a patient to restore healthy gut bacteria — as a treatment for children with ulcerative colitis (UC), an inflammatory bowel disease. It includes both newly diagnosed children and those whose UC hasn't responded to standard therapies. **You may be eligible if...** - Your child is between 2 and 16 years old with no genetic diseases - Your child has been diagnosed with mild to moderate ulcerative colitis - Your child is either newly diagnosed (first-line group) or has not responded to standard treatments like steroids, immunosuppressants, or biologics (refractory group) - Your child and family are willing to undergo regular colonoscopies **You may NOT be eligible if...** - Your child has been on exclusive tube feeding (PEN) for less than 8 weeks - Your child has already received standard medications like steroids, methotrexate, or anti-TNF agents as first-line treatment (for the first-line group) - There are contraindications to all FMT delivery methods (tube, scope, or enema) - Consent or assent cannot be provided Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFecal Microbiota Transplantation

In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.


Locations(1)

Tongji Hospital

Wuhan, China

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NCT05679622


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