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Recruiting
NCT05679622
Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
Conditions: Ulcerative Colitis
Sex: All
Ages: 2 Years – 16 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Biao Zou
Location: Tongji Hospital Wuhan
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 Criteria
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
Source: ClinicalTrials.gov (NCT05679622). StuddyBuddy aggregates publicly available trial information.