Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery

Study Overview
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Brief Summary
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for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.

Detailed Description
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For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.

Official Title
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The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery

Conditions
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Crohn Disease

Intervention / Treatment
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* Dietary Supplement: postoperative 3-month exclusive enteral nutrition
* Drug: azathioprine
* Other: normal diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD patients who undergoing bowel resection with anastomosis Exclusion Criteria: patients who had administered with immunomodulators or biological agents patients who were created stoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 months exclusive enteral nutrition plus azathioprine<br>patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence. | Dietary Supplement: postoperative 3-month exclusive enteral nutrition<br>* postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months<br>Drug: azathioprine<br>* azathioprine<br>|
| Active Comparator: normal diet plus azathioprine<br>patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence. | Drug: azathioprine<br>* azathioprine<br>Other: normal diet<br>* normal diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 1 year postoperative anastomotic recurrence | the 1 year postoperative anastomotic recurrence | 1 year |