Screen-detected Coeliac Disease, a Population Based Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Dietary instruction Gluten-free diet |
Other: Gluten-free diet
Dietary advice by clinical dietitian
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Outcome Measures
Primary Outcome Measures
- Gastrointestinal symptoms: Gastrointestinal symptoms rating scale (GSRS) [7 days]
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)
Secondary Outcome Measures
- Quality of life score: Psychological General Well-Being Index (PGWBI) [7 days]
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)
- Self-reported change in abdominal complaints [One year]
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"
- Self-reported change in energy [One year]
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"
Eligibility Criteria
Criteria
Inclusion Criteria:
- Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and biopsy verified coeliac disease
Exclusion Criteria:
- Previously diagnosed coeliac disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital of North Norway | Tromsø | Norway | 9038 |
Sponsors and Collaborators
- University Hospital of North Norway
- The Norwegian Coeliac Society
- The Gastrointestinal Research Foundation, University Hospital of NorthNorway
Investigators
- Principal Investigator: Jan- M Kvamme, MD PhD, University of Tromso
- Study Chair: Trond Halstensen, MD PhD, University of Oslo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2011/1943 (REK)