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

Not Applicable

Recruiting

• Conditions: Crohn Disease
• Interventions: Dietary Supplement: postoperative 3-month exclusive enteral nutrition; Other: normal diet; Drug: azathioprine

• Registration Number: NCT04160325
• Lead Sponsor: Zhu Weiming

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-11-03
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-13
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal diet plus azathioprine	normal diet	patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
3 months exclusive enteral nutrition plus azathioprine	postoperative 3-month exclusive enteral nutrition	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.
3 months exclusive enteral nutrition plus azathioprine	azathioprine	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.
normal diet plus azathioprine	azathioprine	patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.

Primary Outcome Measures

Name	Time	Method
the 1 year postoperative anastomotic recurrence	1 year	the 1 year postoperative anastomotic recurrence

Trial Locations

Locations (1)

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China