Combined Application of EEN in the Induction of Remission in PUC

Study Overview
=================
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.

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

Conditions
-----------------
Exclusive Enteral Nutrition, Ulcerative Colitis, Children

Intervention / Treatment
-----------------
* Combination Product: exclusive enteral nutrition
* Combination Product: regular food


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEN combined therapy group<br>in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab | Combination Product: exclusive enteral nutrition<br>* Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.<br>* Other names: corticosteroids, infliximab, 5-ASA, AZA;|
| Active Comparator: Non EEN combination group<br>in the induction of remission phase, corticosteroids or infliximab will be used without EEN | Combination Product: regular food<br>* Administration of regular food in the induction phase and the later time.<br>* Other names: corticosteroids, infliximab, 5-ASA, AZA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Treatment modification rate | The rate of new treatment measures needed to be started due to worsening of symptoms. | 1 year after intervention |