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The pathogenesis of Crohn Disease (CD) is unknown, but there is evidence show that the inadequate immune response or overreaction of the immune system against food antigens or components of the commensal flora involve it. Corticosteroid therapy is effective for adult patients with CD, but it has side effects and can't promote mucosal healing. In recent years, Enteral nutrition (EN) is becoming primary therapy in induction and maintenance remission of CD, especially in children. But the mechanism of EN in induction and maintenance remission of CD is still unclear, and parts of patient have good clinical response to EN therapy while other don't. So we design the study to explore whether EN treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD relates with clinical response.
The pathogenesis of CD is unknown, but there is evidence show that the inadequate immune response or overreaction of the immune system against food antigens or components of the commensal flora involve it. Corticosteroid therapy is effective for adult patients with CD, but it has side effects and can't promote mucosal healing. In recent years, EN is becoming primary therapy in induction and maintenance remission of CD, especially in children. But the mechanism of EN in induction and maintenance remission of CD is still unclear, and parts of patient have good clinical response to EN therapy while other don't. So we design the study to explore whether EN treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD relates with clinical response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enteral nutrition | Experimental | The patients receive treatment of enteral nutrition only. |
|
| Corticosteroid | Experimental | The patients receive treatment of corticosteroid only. |
|
| Healthy control | No Intervention | healthy people applied with normal diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enteral nutrition | Dietary Supplement | enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of intestinal flora of stool | Change from baseline in diversity and composition of intestinal flora of stool every week and time point of clinical remission after intervention | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| biochemical indexes | Change from baseline of hematological and biochemical indexes (CRP(C-reactive protein), PCT(procalcitonin), ESR(erythrocyte sedimentation rate), Alb) of blood every week | 6 weeks |
| CDAI(Crohn's disease activity index) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Jinling hosptal,Medical School of Nanjing University | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35935714 | Derived | Guo D, Fang L, Liu R, Li Y, Lv L, Niu Z, Chen D, Zhou Y, Zhu W. Exploring Different Effects of Exclusive Enteral Nutrition (EEN) and Corticosteroids on the Gut Microbiome in Crohn's Disease Based on a Three-Stage Strategy. Gastroenterol Res Pract. 2022 Jul 27;2022:6147124. doi: 10.1155/2022/6147124. eCollection 2022. |
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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 |
|---|---|
| D004750 | Enteral Nutrition |
| D000305 | Adrenal Cortex Hormones |
| D011241 | Prednisone |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| corticosteroid | Drug | corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks) |
|
|
Change from baseline of CDAI every week
| 6 weeks |
| Fecal Calcium Protein | Change from Baseline in Fecal Calcium Protein in every week | 6 weeks |
| D007410 | Intestinal Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D015065 | 17-Hydroxycorticosteroids |