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Combined Application of EEN in the Induction of Remission in PUC

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 3, 2024 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 1, 2024 to Oct 1, 2026
    • Start date: Mar 1, 2024 to Mar 1, 2025
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v7
  2. Start date: Mar 1, 2023 to Mar 1, 2024v6
  3. Start date: Oct 31, 2022 to Mar 1, 2023v5
  4. Start date: May 1, 2022 to Oct 31, 2022v4
  5. Start date: Mar 1, 2022 to May 1, 2022v3
  6. Start date: Oct 1, 2021 to Mar 1, 2022v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear. In this study, EEN will be combined with corticosteroids or infliximab in the induction of remission in pediatric UC patients with moderate to severe disease activity. The mucosal healing rate at week12 will be compared between the two groups (combine with EEN group VS non-combine group).
Trial Details
NCT Number NCT04999241
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Exclusive Enteral Nutrition, Ulcerative Colitis, Children
Related terms Colitis, Ulcerative
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov