NCT05214430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

January 26, 2022

Last Update Submit

October 16, 2023

Conditions

Crohn Disease in Remission

Outcome Measures

Primary Outcomes (1)

  • postoperative endoscopic recurrence

    over i2b of rutgeerts score

    1 YEAR

Study Arms (2)

3 months exclusive enteral nutrition after surgery

EXPERIMENTAL

3 months exclusive enteral nutrition after surgery

Other: 3 months exclusive enteral nutrition after surgery

less than 1 months exclusive enteral nutrition after surgery

EXPERIMENTAL

less than 1 months exclusive enteral nutrition after surgery

Other: 3 months exclusive enteral nutrition after surgery

Interventions

3 months exclusive enteral nutrition after surgeryOTHER

patients underwent intestinal resection and anastomosis in this arm will given over 3 months exclusive enteral nutrition,and free diet after 3 months.

3 months exclusive enteral nutrition after surgeryless than 1 months exclusive enteral nutrition after surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- CD patients who undergoing bowel resection with anastomosis

You may not qualify if:

  • patients who received stoma creation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

  • Duan M, Lu M, Diao Y, Cao L, Wu Q, Liu Y, Gong J, Zhu W, Li Y. Azathioprine Plus Exclusive Enteral Nutrition Versus Azathioprine Monotherapy for the Prevention of Postoperative Recurrence in Patients with Crohn's Disease: An Open-Label, Single-Centre, Randomized Controlled Trial. J Crohns Colitis. 2024 Aug 6;18(7):1113-1121. doi: 10.1093/ecco-jcc/jjae015.

    PMID: 38253914DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jinling Hospital, China

Study Record Dates

First Submitted

January 26, 2022

First Posted

January 28, 2022

Study Start

January 1, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)