Screen-detected Coeliac Disease, a Population Based Study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life|
- Gastrointestinal symptoms [ Time Frame: One year ] [ Designated as safety issue: No ]Change in GSRS (Gastrointestinal symptoms rating scale) score at 1 year compared to baseline
- Quality of Life [ Time Frame: One year ] [ Designated as safety issue: No ]Change in Quality of Life score (PGWBI - Psychological General Well-Being Index) at 1 year compared to baseline
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Other: Gluten-free diet
Dietary advice by clinical dietitian
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695681
|University hospital of North Norway|
|Tromsoe, Norway, 9038|
|Principal Investigator:||Jan- M Kvamme, MD PhD||University of Tromso|
|Study Chair:||Trond Halstensen, MD PhD||University of Oslo|