Combined Application of EEN in the Induction of Remission in PUC

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04999241
• Other study ID #: UC1.2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Children's Hospital of Fudan University
• Contact: Cui fang Zheng
• Phone: 8615221881022
• Email: zhengcuifang2[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Colitis
• Colitis, Ulcerative
• Exclusive Enteral Nutrition
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mucosal healing rate	The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ?1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.	12 week after intervention
Secondary	sustained corticosteroid-free clinical remission rate	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.	1 year after intervention
Secondary	Treatment modification rate	The rate of new treatment measures needed to be started due to worsening of symptoms.	1 year after intervention