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Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05214430
Recruitment Status : Completed
First Posted : January 28, 2022
Last Update Posted : October 17, 2023
Sponsor:
Information provided by (Responsible Party):
Zhu Weiming, Jinling Hospital, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn Disease in Remission Other: 3 months exclusive enteral nutrition after surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: 3 months exclusive enteral nutrition after surgery
3 months exclusive enteral nutrition after surgery
 Other: 3 months exclusive enteral nutrition after surgery
patients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months.
Experimental: less than 1 months exclusive enteral nutrition after surgery
less than 1 months exclusive enteral nutrition after surgery
 Other: 3 months exclusive enteral nutrition after surgery
patients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months.


Outcome Measures
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Primary Outcome Measures :
  1. postoperative endoscopic recurrence [ Time Frame: 1 YEAR ]
    over i2b of rutgeerts score


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

  • patients who received stoma creation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214430


Locations
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China, Jiangsu
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China
More Information
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Responsible Party: Zhu Weiming, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT05214430    
Other Study ID Numbers: jinlingH202001
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: October 17, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases