Multimodal Approach in IBD Patients

• Conditions: Crohn's Disease; Nonalcoholic Fatty Liver Disease (NAFLD); Vitamin D Deficiency; Ulcerative Colitis

• Registration Number: NCT01705522
• Lead Sponsor: Clinical Hospital Colentina

Brief Summary

The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.

Detailed Description

Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.

Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.

Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).

Data about current and past medication for IBD will also be gathered.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ulcerative colitis or Crohn's disease
• age over 18
• clinical remission
• signed informed consent

Exclusion Criteria

• pregnant women
• refusal to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical relapse	1 year	clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI
Prevalence of NAFLD	1 year	to assess the prevalence of nonalcoholic liver disease in IBD patients
prevalence of vitamin D deficiency	1 year	to assess vitamin D deficiency and osteopenia among IBD patients

Trial Locations

Locations (1)

Colentina Clinical Hospital; 🇷🇴 Bucharest, Romania