Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment Clinical Trial
| NCT number | NCT02887287 |
| Other study ID # | E2016008 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | August 29, 2016 |
| Last updated | September 1, 2016 |
| Start date | July 2013 |
The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - >18 years old - Patients with CD was diagnosed clinically according to previously established international criteria [9] - The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis. Exclusion Criteria: - Patients do not macth the inclusion criteria and those who refuse to taking part in the study |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | The six affiliated hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Yat-sen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical remission after 12 weeks EEN | July 2013 to October 2015 | No |