Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases After Surgery

Sponsor

Zhu Weiming (Other)

Overall Status

Recruiting

CT.gov ID

NCT04160325

Collaborator

(none)

Enrollment

Location

Arms

67.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.

Condition or Disease	Intervention/Treatment	Phase
Crohn Disease	Dietary Supplement: postoperative 3-month exclusive enteral nutrition Drug: azathioprine Other: normal diet	N/A

Detailed Description

For patients with Crohn's disease(CD), whether exclusive enteral nutrition(EEN) following bowel resection and anastomosis could delay the disease recurrence remains unkown. In this study， CD patients after surgery will be divided into two groups: one group is treated with 3 months' EEN and then turn to normal diet after 3 months; the other group is given with normal diet all through. All patients will be adminstrated with oral azathioprine after surgery. Then, the rates of 1 year postoperative endoscopic recurrence will be compared between groups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery

Actual Study Start Date :

May 14, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3 months exclusive enteral nutrition plus azathioprine patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.	Dietary Supplement: postoperative 3-month exclusive enteral nutrition postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months Drug: azathioprine azathioprine
Active Comparator: normal diet plus azathioprine patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.	Drug: azathioprine azathioprine Other: normal diet normal diet

Arm

Intervention/Treatment

Experimental: 3 months exclusive enteral nutrition plus azathioprine

patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.

Dietary Supplement: postoperative 3-month exclusive enteral nutrition

postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months

Drug: azathioprine

azathioprine

Active Comparator: normal diet plus azathioprine

patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.

Drug: azathioprine

azathioprine

Other: normal diet

normal diet

Outcome Measures

Primary Outcome Measures

the 1 year postoperative anastomotic recurrence [1 year]
the 1 year postoperative anastomotic recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

patients who had administered with immunomodulators or biological agents patients who were created stoma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu	China	210002

Sponsors and Collaborators

Zhu Weiming

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhu Weiming, Director, Head of General Surgery, Principal Investigator, Clinical Professor, Jinling Hospital, China

ClinicalTrials.gov Identifier:

NCT04160325

Other Study ID Numbers:

jinlingH201709

First Posted:

Nov 13, 2019

Last Update Posted:

Feb 23, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Crohn Disease

Azathioprine

Study Results

No Results Posted as of Feb 23, 2022