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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EEN combined therapy group | Experimental | in the induction of remission phase, EEN will be used combine with corticosteroids or infliximab |
|
| Non EEN combination group | Active Comparator | in the induction of remission phase, corticosteroids or infliximab will be used without EEN |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exclusive enteral nutrition | Combination Product | Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cui fang Zheng | Contact | 8615221881022 | zhengcuifang2@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Huang | Children's Hospital of Fudan University | Study Director |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000069285 | Infliximab |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
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|
| regular food | Combination Product | Administration of regular food in the induction phase and the later time. |
|
|
| Treatment modification rate |
The rate of new treatment measures needed to be started due to worsening of symptoms. |
| 1 year after intervention |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |