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prospectively compared Exclusive Enteral Nutrition with Infliximab in the clinical outcomes, mucosal healing, nutrition improvements, adverse effects and gastrointestinal microbiota changes on Chinese Children With active Crohn's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive enteral nutrition | Experimental | the administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement). |
|
| Infliximab | Active Comparator | the participants with active CD accept anti-TNF therapy (Infliximab) at 0week, 2week, 6week, 14week. Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients who reach mucosal healing at the end of treatment in Exclusive enteral nutrition group | the mucosal healing was defined as Simple Endoscopic Score for CD (SES-CD )≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe>16. | at the end of 8 week of treatment. |
| the number of patients who reach mucosal healing at the end of treatment in Infliximab group | the mucosal healing was defined as Simple Endoscopic Score for CD (SES-CD )≤4 at the end of treatment . For the SES-CD, the intestine is divided into 5 anatomic segments under the endoscopic vision: rectum, left side of the colon segment, transverse colon, right side of the colon segment, and ileum. Items of interest include ulcer size, estimates of the ulcerated and affected surface, and the presence of luminal narrowing. The SES-CD score is calculated by combining scores of individual segments. Overall SES-CD scores are classified into 4 disease categories: none, 0 to 2; mild 2 to 4; moderate 5 to 15; and severe>16. | at the end of 14 week of treatment. |
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Inclusion Criteria:
patients:
healthy controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Huang, Dr | Department of Gastroenterology, Pediatric Inflammatory Bowel Disease Research Center, Children's Hospital of Fudan University | Study Chair |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Exclusive Enteral Nutrition | Dietary Supplement | the administration of a liquid formula diet with the exclusion of all other regular food for 6-8 weeks, the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement). |
|
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |