Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: Screen detected CeD
Group B: Potential CeD

Trial outcomes

Primary outcomes

1

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.

Time frame
At the time of study visit
2

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.

Time frame
At the time of study visit

Secondary outcomes

1

Celiac disease diagnosis

How many have received celiac disease diagnosis after previous study?

Time frame
2-20 years
2

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.

Time frame
The time of study visit
3

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

Time frame
At the time of study visit
4

BMI

Weight (kilograms) and height (centimeters) will be combined as body mass index, kg/m2

Time frame
At the time of the study

Other outcomes

Sponsors and contacts

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Tampere University Hospital

Lead sponsor

Tampere University

Collaborator

Finnish Medical Foundation

Collaborator

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