Children, Exclusive Enteral Nutrition, Ulcerative Colitis
Conditions
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.
Interventions
COMBINATION_PRODUCTexclusive 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.
COMBINATION_PRODUCTregular food
Administration of regular food in the induction phase and the later time.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactCui fang Zheng
Outcome results
None listed