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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Dietary supplement: postoperative 3-month exclusive enteral nutrition; Drug: azathioprine; Other: normal diet

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: weiming zhu; Phone Number: +86-025-80860036; Email: juwiming@nju.edu.cn
• Study Contact Backup: Name: ming duan; Phone Number: +86-025-80860037; Email: duanming1206@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
      • Contact: Weiming Zhu, PhD; Phone Number: 86-25-80863736; Email: juwiming@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: postoperative 3-month exclusive enteral nutrition; postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months; Drug: azathioprine; azathioprine
Active Comparator: 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.	Drug: azathioprine; azathioprine; Other: normal diet; normal diet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhu Weiming

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Azathioprine
• Other Study ID Numbers: jinlingH201709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No