Combined Application of EEN in the Induction of Remission in PUC

Phase 4

Not yet recruiting

• Conditions: Exclusive Enteral Nutrition; Ulcerative Colitis; Children
• Interventions: Combination Product: exclusive enteral nutrition; Combination Product: regular food

• Registration Number: NCT04999241
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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).

Detailed Description

The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease(CD) had been well documented. Several randomized controlled trial studies found that the overall induction of remission was equipotent with EEN compared to corticosteroids for pediatric CD. However, in promoting mucosal healing and improving the nutritional status, EEN was much better than corticosteroids. 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 week 12 will be compared between the two groups (combine with EEN group VS non-combine group).The sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Study Start: 2025-03-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Newly diagnosed UC
2. Years 6 to 18
3. Moderate to severe disease activity at diagnosis

Exclusion Criteria

1. With mild disease activity at diagnosis
2. Had been treated with corticosteroids or biologics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEN combined therapy group	exclusive enteral nutrition	in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab
Non EEN combination group	regular food	in the induction of remission phase, corticosteroids or infliximab will be used without EEN

Primary Outcome Measures

Name	Time	Method
The mucosal healing rate	12 week after intervention	The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.

Secondary Outcome Measures

Name	Time	Method
sustained corticosteroid-free clinical remission rate	1 year after intervention	Sustained pediatric Ulcerative Colitis activity index (PUCAI) score \<10 points during follow-up (week 14 to week 54 after intervention) without the treatment of corticosteroids . This will be evaluated by gastroenterologist.
Treatment modification rate	1 year after intervention	The rate of new treatment measures needed to be started due to worsening of symptoms.