Screen-detected Coeliac Disease, a Population Based Study
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|ClinicalTrials.gov Identifier: NCT01695681|
Recruitment Status : Unknown
Verified November 2016 by University Hospital of North Norway.
Recruitment status was: Active, not recruiting
First Posted : September 28, 2012
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease||Other: Gluten-free diet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screen-detected Coeliac Disease. Prevalence and Impact on Gastrointestinal Symptoms and Quality of Life|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2017|
Other: Gluten-free diet
Dietary advice by clinical dietitian
- Gastrointestinal symptoms [ Time Frame: One year ]Change in GSRS (Gastrointestinal symptoms rating scale) score at 1 year compared to baseline
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|