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

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