Combined Application of EEN in the Induction of Remission in PUC

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04999241

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Exclusive Enteral Nutrition Ulcerative Colitis Children	Combination Product: exclusive enteral nutrition Combination Product: regular food	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 31, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EEN combined therapy group in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab	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. Other Names: corticosteroids, infliximab, 5-ASA, AZA
Active Comparator: Non EEN combination group in the induction of remission phase, corticosteroids or infliximab will be used without EEN	Combination Product: regular food Administration of regular food in the induction phase and the later time. Other Names: corticosteroids, infliximab, 5-ASA, AZA

Arm

Intervention/Treatment

Experimental: EEN combined therapy group

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

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.

Other Names:

corticosteroids, infliximab, 5-ASA, AZA

Active Comparator: Non EEN combination group

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

Combination Product: regular food

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

Other Names:

corticosteroids, infliximab, 5-ASA, AZA

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed UC
Years 6 to 18
Moderate to severe disease activity at diagnosis

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

Study Director: Ying Huang, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying HUANG, Chief of Gastroenterology, Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT04999241

Other Study ID Numbers:

UC1.2

First Posted:

Aug 10, 2021

Last Update Posted:

Aug 2, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022