Back to resultsEffect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery
Primary Purpose
Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
postoperative 3-month exclusive enteral nutrition
azathioprine
normal diet
Sponsored by
About this trial
This is an interventional prevention trial for Crohn Disease
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
Sites / Locations
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3 months exclusive enteral nutrition plus azathioprine
normal diet plus azathioprine
Arm Description
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.
patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
Outcomes
Primary Outcome Measures
the 1 year postoperative anastomotic recurrence
the 1 year postoperative anastomotic recurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160325
Brief Title
Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery
Official Title
The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhu Weiming
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 months exclusive enteral nutrition plus azathioprine
Arm Type
Experimental
Arm Description
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.
Arm Title
normal diet plus azathioprine
Arm Type
Active Comparator
Arm Description
patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.
Intervention Type
Dietary Supplement
Intervention Name(s)
postoperative 3-month exclusive enteral nutrition
Intervention Description
postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months
Intervention Type
Drug
Intervention Name(s)
azathioprine
Intervention Description
azathioprine
Intervention Type
Other
Intervention Name(s)
normal diet
Intervention Description
normal diet
Primary Outcome Measure Information:
Title
the 1 year postoperative anastomotic recurrence
Description
the 1 year postoperative anastomotic recurrence
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weiming zhu
Phone
+86-025-80860036
Email
juwiming@nju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
ming duan
Phone
+86-025-80860037
Email
duanming1206@126.com
Facility Information:
Facility Name
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiming Zhu, PhD
Phone
86-25-80863736
Email
juwiming@nju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery
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