Clinical Trial: Screen-detected Coeliac Disease, a Population Based Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life

Brief Summary: The purpose of this study is to determine the prevalence of previously undiagnosed coeliac disease based on a health survey from Tromsø, Norway. Moreover, the health impact of undiagnosed coeliac disease will be examined.

Detailed Summary:

Few population-based studies have examined the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health. Moreover, the number of people with undiagnosed coeliac disease is much higher than the number who know their diagnosis.

The purpose of this study is to determine the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health.

In a health survey of the population of Tromsø Norway, serological markers of coeliac disease (transglutaminase 2, TG2 and deamidated gliadin antibody test) have been analyzed. Individuals with increased level of one of these markers, will be invited for upper endoscopy with small bowel biopsy examination to confirm the diagnosis of coeliac disease. All persons with screen detected coeliac disease, will be advised to start a gluten free diet.

Health status and Quality of Life will be examined by means of the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI) respectively.

  1. At baseline GSRS and PGWBI will be analyzed in persons with screen detected and biopsy verified coeliac disease and compared with a group of healthy control persons from the health-survey cohort.
  2. In a prospective study of the persons with screen detected coeliac disease, health status (GSRS) and Quality of Life will be compared before and after one year on a gluten free diet.

Sponsor: University Hospital of North Norway

Current Primary Outcome: Gastrointestinal symptoms [ Time Frame: One year ]

Change in GSRS (Gastrointestinal symptoms rating scale) score at 1 year compared to baseline


Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of Life [ Time Frame: One year ]

Change in Quality of Life score (PGWBI - Psychological General Well-Being Index) at 1 year compared to baseline


Original Secondary Outcome: Same as current

Information By: University Hospital of North Norway

Dates:
Date Received: September 26, 2012
Date Started: October 2012
Date Completion: September 2017
Last Updated: November 28, 2016
Last Verified: November 2016