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

Z

Zhu Weiming

Status

Enrolling

Conditions

Crohn Disease

Treatments

Other: normal diet
Drug: azathioprine
Dietary Supplement: postoperative 3-month exclusive enteral nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT04160325
jinlingH201709

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

weiming zhu; ming duan

Data sourced from clinicaltrials.gov

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