Clinical Trials Directory

Trials / Completed

CompletedNCT01695681

Screen-detected Coeliac Disease, a Population Based Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
172 (actual)
Sponsor
University Hospital of North Norway · Academic / Other
Sex
All
Age
30 Years – 87 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
OTHERGluten-free dietDietary advice by clinical dietitian

Timeline

Start date
2012-10-01
Primary completion
2015-04-15
Completion
2015-04-15
First posted
2012-09-28
Last updated
2020-03-11

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01695681. Inclusion in this directory is not an endorsement.