Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery

• ClinicalTrials.gov Identifier: NCT05214430
• Recruitment Status: Completed
• First Posted: January 28, 2022
• Last Update Posted: October 17, 2023
• Sponsor: Jinling Hospital, China
• Information provided by (Responsible Party): Zhu Weiming, Jinling Hospital, China

Tracking Information

• First Submitted Date: January 26, 2022
• First Posted Date: January 28, 2022
• Last Update Posted Date: October 17, 2023
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2022)

postoperative endoscopic recurrence [ Time Frame: 1 YEAR ]

over i2b of rutgeerts score

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
• Official Title: Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Crohn Disease in Remission

Intervention

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.

Study Arms

• Experimental: 3 months exclusive enteral nutrition after surgery
  3 months exclusive enteral nutrition after surgery
  Intervention: Other: 3 months exclusive enteral nutrition after surgery
• Experimental: less than 1 months exclusive enteral nutrition after surgery
  less than 1 months exclusive enteral nutrition after surgery
  Intervention: Other: 3 months exclusive enteral nutrition after surgery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2023): 84
• Original Estimated Enrollment (submitted: January 26, 2022): 198
• Actual Study Completion Date: July 31, 2023
• Actual Primary Completion Date: July 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

• patients who received stoma creation

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05214430
• Other Study ID Numbers: jinlingH202001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Zhu Weiming, Jinling Hospital, China
• Original Responsible Party: Same as current
• Current Study Sponsor: Jinling Hospital, China
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jinling Hospital, China
• Verification Date: October 2023