Clinical Trials Directory

Trials / Completed

CompletedNCT05815355

Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease

Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment

Status
Completed
Phase
Study type
Observational
Enrollment
48 (actual)
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Patients with Crohn's disease (CD) could develop complications such as stricture, intestinal fistula and abdominal abscess. Some CD patients had poor response to medical therapy. The efficacy of exclusive enteral nutrition (EEN) to these adult active CD patients is still unclear. The investigators aim to study the efficacy of EEN in induction of remission in adult active CD patients with complications or poor response to drugs.

Detailed description

Active CD patients following up in our center who had been diagnosed as complicated disease with stricture, intestinal fistula, abdominal abscess and no response to drugs, were recruited since July 2013. Patients were only offered EEN for 12 weeks without using other drugs except that patients with abscess could use antibiotic therapy with or without percutaneous drainage. The disease activity was assessed by the Crohn's disease activity index (CDAI). CDAI\<150 was taken as achieving clinical remission. Demographics and clinical variables were recorded. Nutritional (body mass index, albumin) and inflammatory (High sensitivity C-reactive protein and platelet) index were evaluated at baseline, week 4 and week 12. Some patients performed colonoscopy and/or computed tomography enterography (CTE) /resonance enterography(MRE) before and after EEN. Mucosal healing was assessed under endoscopy with SES-CD and the size of abscess was detected by CTE /MRE.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTexclusive enteral nutrition treatment group

Timeline

Start date
2013-07-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2023-04-18
Last updated
2023-04-18

Source: ClinicalTrials.gov record NCT05815355. Inclusion in this directory is not an endorsement.