Screen-detected Coeliac Disease, a Population Based Study
NCT ID: NCT01695681
Last Updated: 2020-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2012-10-01
2015-04-15
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Dietary instruction
Gluten-free diet
Gluten-free diet
Dietary advice by clinical dietitian
Interventions
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Gluten-free diet
Dietary advice by clinical dietitian
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
30 Years
87 Years
ALL
No
Sponsors
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The Norwegian Coeliac Society
UNKNOWN
The Gastrointestinal Research Foundation, University Hospital of NorthNorway
UNKNOWN
University Hospital of North Norway
OTHER
Responsible Party
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Principal Investigators
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Jan- M Kvamme, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tromso
Trond Halstensen, MD PhD
Role: STUDY_CHAIR
University of Oslo
Locations
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University hospital of North Norway
Tromsø, , Norway
Countries
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References
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Kvamme JM, Sorbye S, Florholmen J, Halstensen TS. Population-based screening for celiac disease reveals that the majority of patients are undiagnosed and improve on a gluten-free diet. Sci Rep. 2022 Jul 25;12(1):12647. doi: 10.1038/s41598-022-16705-2.
Other Identifiers
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2011/1943 (REK)
Identifier Type: -
Identifier Source: org_study_id
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