The Role of Combined Application of Exclusive Enteral Nutrition in the Induction of Remission for Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Exclusive Enteral Nutrition
- Sponsor
- Children's Hospital of Fudan University
- Enrollment
- 40
- Primary Endpoint
- The mucosal healing rate
- Status
- Not yet recruiting
- Last Updated
- last year
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.
Investigators
Ying HUANG
Chief of Gastroenterology
Children's Hospital of Fudan University
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
Outcomes
Primary Outcomes
The mucosal healing rate
Time Frame: 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 Outcomes
- sustained corticosteroid-free clinical remission rate(1 year after intervention)
- Treatment modification rate(1 year after intervention)