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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160325
• Other study ID #: jinlingH201709
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: October 31, 2023

Study information

• Verified date: October 2023
• Source: Jinling Hospital, China
• Contact: weiming zhu
• Phone: +86-025-80860036
• Email: juwiming[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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

Other:
• normal diet
normal diet

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Weiming

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the 1 year postoperative anastomotic recurrence	the 1 year postoperative anastomotic recurrence	1 year