Using exclusive enteral nutrition and azathioprine to prevent Crohn's disease relapse after surgery
The Effect of the Exclusive Enteral Nutrition Combined With Azathioprine in Maintaining Remission of Patients With Crohn's Diseases After Surgery
NA · Jinling Hospital, China · NCT04160325
This study is testing if a special diet called exclusive enteral nutrition, along with a medication, can help prevent Crohn's disease from coming back after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China (other) |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT04160325 on ClinicalTrials.gov |
What this trial studies
This study investigates whether exclusive enteral nutrition (EEN) can delay the recurrence of Crohn's disease in patients who have undergone bowel resection and anastomosis. Participants will be divided into two groups: one receiving EEN for three months followed by a normal diet, and the other continuing with a normal diet throughout. All patients will also receive oral azathioprine post-surgery. The primary outcome will be the comparison of endoscopic recurrence rates one year after surgery between the two groups.
Who should consider this trial
Good fit: Ideal candidates are patients with Crohn's disease who are scheduled to undergo bowel resection with anastomosis.
Not a fit: Patients who have previously received immunomodulators or biological agents, or those who have undergone stoma creation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve remission rates and quality of life for patients with Crohn's disease after surgery.
How similar studies have performed: While the use of exclusive enteral nutrition in Crohn's disease is explored, this specific combination with azathioprine post-surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing University — Nanjing, Jiangsu, China (RECRUITING)
Study contacts
- Study coordinator: weiming zhu
- Email: juwiming@nju.edu.cn
- Phone: +86-025-80860036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease