Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult (EN)
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|ClinicalTrials.gov Identifier: NCT02056418|
Recruitment Status : Unknown
Verified February 2014 by Zhu Weiming, Jinling Hospital, China.
Recruitment status was: Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Dietary Supplement: enteral nutrition Drug: corticosteroid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Experimental: enteral nutrition
The patients receive treatment of enteral nutrition only.
Dietary Supplement: enteral nutrition
enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)
The patients receive treatment of corticosteroid only.
corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)
No Intervention: Healthy control
healthy people applied with normal diet.
- change of intestinal flora of stool [ Time Frame: 6 weeks ]Change from baseline in diversity and composition of intestinal flora of stool every week and time point of clinical remission after intervention
- biochemical indexes [ Time Frame: 6 weeks ]Change from baseline of hematological and biochemical indexes (CRP(C-reactive protein), PCT(procalcitonin), ESR(erythrocyte sedimentation rate), Alb) of blood every week
- CDAI(Crohn's disease activity index) [ Time Frame: 6 weeks ]Change from baseline of CDAI every week
- Fecal Calcium Protein [ Time Frame: 6 weeks ]Change from Baseline in Fecal Calcium Protein in every week
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056418
|Department of General Surgery, Jinling hosptal,Medical School of Nanjing University|
|Nanjing, Jiangsu, China, 210002|