Celiac Disease
Conditions
Keywords
Quality of life, Celiac Disease/diet therapy, Celiac Disease/diagnosis, Prospective Studies
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.
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.
Interventions
OTHERGluten-free diet
Dietary advice by clinical dietitian
Sponsors
The Norwegian Coeliac Society
The Gastrointestinal Research Foundation, University Hospital of NorthNorway
University Hospital of North Norway
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 87 Years
Healthy volunteers
No
Inclusion criteria
* Increased level of serological markers (Transglutaminase 2 or Deamidated Gliadin) and biopsy verified coeliac disease
Exclusion criteria
* Previously diagnosed coeliac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Outcome results
None listed