Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery

October 16, 2023 updated by: Zhu Weiming, Jinling Hospital, China
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

  • patients who received stoma creation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative endoscopic recurrence
Time Frame: 1 YEAR
over i2b of rutgeerts score
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 28, 2022

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

Other Study ID Numbers

  • jinlingH202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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