About this trial
The primary aim of this project is to investigate how active screening and the timing of diagnosis affect the long-term health outcomes of patients with celiac disease. Additionally, the study seeks to clarify the natural course of so-called potential celiac disease. A key focus is also placed on assessing adherence to a gluten-free diet among screen-detected and, if initiated, potential celiac disease patients, their satisfaction with the diagnosis, and the diet's impact on general health and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Finnish citizenship and current residence in Finland
Disqualifiers
Age <18 years
Trial population
Participants of earlier study cohorts investigating potential or screen-detected celiac disease, irrespective of the current diagnostical status.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Gastrointestinal symptom rating scale (GSRS)
Symptoms are measured with Gastrointestinal symptom rating scale (GSRS) questionnaire. The scoring consists of 15 items, which are scored with a 7-grade Likert scale in which 1 point indicates no symptoms and 7 points the most severe gastrointestinal symptoms. Items cover five different symptoms (indigestion, diarrhea, abdominal pain, constipation and reflux) and values for each sub-dimension are calculated as a mean of the relevant items. The total GSRS score is described as a mean value of all 15 items (from 1 to 7 points). Scores of the participants are compared with the result of earlier study when possible.
Quality of life (PGWB)
Quality of life is measured with Psychological General Well-Being (PGWB) questionnaire. The survey consists of 22 separate items covering six different sub-dimensions: anxiety, depression, well-being, self-control, general health and vitality. The scoring is based on a 6-grade Likert scale in which higher scores indicate better quality of life. The value of the total PGWB score may range from a minimum of 22 to maximum 132. The sub-scores are calculated as a sum of the items in each sub-dimensio. The PGWB results are compared with the result of earlier study when possible.
Secondary outcomes
Celiac disease diagnosis
How many have received celiac disease diagnosis after previous study?
Gluten-free diet
Adherence to the dietary treatment, when initiated is assessed by food diaries and Celiac Disease Adherence Test (CDAT) questionnaire. CDAT questionnaire is a 7-item questionnaire. Scoring is from 7 to 35, in which lower scores indicate good adherence and higher scores point towards poor adherence to gluten-free diet.
Skin symptoms
Interview and Dermatology Life Quality Index (DLQI) questionnaire. The DLQI is dermatology-spesific index with 10 questonnaire considering the impact of skin disease to quality of life during the last week. Each question is scored with a 4-point Likert scale (0-3), giving the total DLQI score from 0 to 30, a higher score indicating worse quality of life
BMI
Weight (kilograms) and height (centimeters) will be combined as body mass index, kg/m2
Sponsors and contacts
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Tampere University Hospital
Lead sponsor
Tampere University
Collaborator
Finnish Medical Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options: