Combined Application of EEN in the Induction of Remission in PUC

NCT ID: NCT04999241

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-12-31

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.

Conditions

Exclusive Enteral Nutrition; Ulcerative Colitis; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EEN combined therapy group

in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab

Group Type: EXPERIMENTAL

exclusive enteral nutrition

Intervention Type: COMBINATION_PRODUCT

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

Non EEN combination group

in the induction of remission phase, corticosteroids or infliximab will be used without EEN

Group Type: ACTIVE_COMPARATOR

regular food

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

regular food

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

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

corticosteroids, infliximab, 5-ASA, AZA; corticosteroids, infliximab, 5-ASA, AZA

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ying HUANG

Chief of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Huang

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Central Contacts

Cui fang Zheng

Role: CONTACT

zhengcuifang2@126.com

8615221881022

Other Identifiers

UC1.2

Identifier Type: -

Identifier Source: org_study_id