Combined Application of EEN in the Induction of Remission in PUC

Fudan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Exclusive Enteral Nutrition; Children; Ulcerative Colitis

Treatments: Combination Product: regular food; Combination Product: exclusive enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04999241

UC1.2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

EEN combined therapy group

Experimental group

Description:

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

Treatment:

Combination Product: exclusive enteral nutrition

Non EEN combination group

Active Comparator group

Description:

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

Treatment:

Combination Product: regular food