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

NCT ID: NCT04160325

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-10-31

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

3 months exclusive enteral nutrition plus 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.

Group Type: EXPERIMENTAL

postoperative 3-month exclusive enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months

azathioprine

Intervention Type: DRUG

azathioprine

normal diet plus 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.

Group Type: ACTIVE_COMPARATOR

azathioprine

Intervention Type: DRUG

azathioprine

normal diet

Intervention Type: OTHER

normal diet

Interventions

postoperative 3-month exclusive enteral nutrition

postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months

Intervention Type: DIETARY_SUPPLEMENT

azathioprine

azathioprine

Intervention Type: DRUG

normal diet

normal diet

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhu Weiming

OTHER

Sponsor Role: lead

Responsible Party

Zhu Weiming

Director, Head of General Surgery, Principal Investigator, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

weiming zhu

Role: CONTACT

juwiming@nju.edu.cn

+86-025-80860036

ming duan

Role: CONTACT

duanming1206@126.com

+86-025-80860037

Facility Contacts

Weiming Zhu, PhD

Role: primary

juwiming@nju.edu.cn

86-25-80863736

Other Identifiers

jinlingH201709

Identifier Type: -

Identifier Source: org_study_id