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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.
Administration of regular food in the induction phase and the later time.
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.
Time frame: 12 week after intervention
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.
Time frame: 1 year after intervention
Treatment modification rate
The rate of new treatment measures needed to be started due to worsening of symptoms.
Time frame: 1 year after intervention
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