Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

Condition(s) studied

Investigational drug(s) / intervention(s)

Fecal 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.

Study 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

Primary outcome measure(s)

• clinical response — 8-12 weeks after FMT
  reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline
• clinical remission — 8-12 weeks after FMT
  Clinical remission defined as a PUCAI \<10
• safety of FMT — 8-12 weeks after FMT
  All possible adverse events: fever, abdominal pain, infectious diseases and others.

Trial sites (1)

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