Screen-detected Coeliac Disease, a Population Based Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Celiac Disease

Intervention / Treatment
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* Other: Gluten-free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and biopsy verified coeliac disease Exclusion Criteria: Previously diagnosed coeliac disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 87 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dietary instruction<br>Gluten-free diet | Other: Gluten-free diet<br>* Dietary advice by clinical dietitian<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS) | The Gastrointestinal symptoms rating scale (GSRS) is a disease-specific instrument with 15 items combined into five major domains: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The scale assesses symptom severity using a seven-grade Likert scale, ranging from 1 (no discomfort at all) to 7 (very severe discomfort). A lower score indicates less symptoms. GSRS is obtained at first visit and at follow-up (>one year) to evaluate change in one of the five domain scores or total score (primary outcome) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score: Psychological General Well-Being Index (PGWBI) | The Psychological General Well-Being Index (PGWBI) is a generic instrument with 22 items combined into six major domains: Anxiety, Depressed Mode, Positive well-being, Self-control, General Health and Vitality The scale assesses symptom severity from 0 to 5. Higher score indicates a better psychological well being. PGWB is obtained at first visit and at follow-up (>one year) to evaluate change in one of the six domains or total score (secondary outcome) | 7 days | 
| Self-reported change in abdominal complaints | Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about abdominal complaints after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from very much worse to very much better | One year | 
| Self-reported change in energy | Retrospective assessment at follow-up: The participants with diagnosed celiac disease were asked about energy/feeling-fit after the change to a gluten-free diet. The question was answered on a 7-grade Likert scale from very much worse to very much better | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Celiac Disease/diet therapy, Celiac Disease/diagnosis, Prospective Studies