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NOT YET RECRUITING
NCT04999241
PHASE4

Combined Application of EEN in the Induction of Remission in PUC

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

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).

Official title: The Role of Combined Application of Exclusive Enteral Nutrition in the Induction of Remission for Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-03-01

Completion Date

2027-12-31

Last Updated

2024-07-03

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

exclusive enteral nutrition

Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.

COMBINATION_PRODUCT

regular food

Administration of regular food in the induction phase and the later time.