Back to resultsExclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Primary Purpose
Crohn Disease in Remission
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3 months exclusive enteral nutrition after surgery
Sponsored by
About this trial
This is an interventional prevention trial for Crohn Disease in Remission
Eligibility Criteria
Inclusion Criteria:
- CD patients who undergoing bowel resection with anastomosis
Exclusion Criteria:
- patients who received stoma creation
Sites / Locations
- General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
3 months exclusive enteral nutrition after surgery
less than 1 months exclusive enteral nutrition after surgery
Arm Description
3 months exclusive enteral nutrition after surgery
less than 1 months exclusive enteral nutrition after surgery
Outcomes
Primary Outcome Measures
postoperative endoscopic recurrence
over i2b of rutgeerts score
Secondary Outcome Measures
Full Information
NCT ID
NCT05214430
First Posted
January 26, 2022
Last Updated
October 16, 2023
Sponsor
Jinling Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05214430
Brief Title
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Official Title
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
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 patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will investigate the efficacy of postoperative EEN for maintaining disease remission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease in Remission
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 months exclusive enteral nutrition after surgery
Arm Type
Experimental
Arm Description
3 months exclusive enteral nutrition after surgery
Arm Title
less than 1 months exclusive enteral nutrition after surgery
Arm Type
Experimental
Arm Description
less than 1 months exclusive enteral nutrition after surgery
Intervention Type
Other
Intervention Name(s)
3 months exclusive enteral nutrition after surgery
Intervention Description
patients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months.
Primary Outcome Measure Information:
Title
postoperative endoscopic recurrence
Description
over i2b of rutgeerts score
Time Frame
1 YEAR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- CD patients who undergoing bowel resection with anastomosis
Exclusion Criteria:
patients who received stoma creation
Facility Information:
Facility Name
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
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