Improved Diagnostics of Celiac Disease in Children

Study Overview
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Brief Summary
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The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.

Detailed Description
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Prevalence of celiac disease is on a steep rise in Western countries, but due to difficult diagnosis the majority of patients remain unrecognized. Undiagnosed celiac disease causes incremental burden to the health care and predisposes to severe complications. On the other hand, increasing screening in at-risk groups of celiac disease frequently detects seropositive subjects with no obvious symptoms and/or still normal small-bowel mucosal morphology. At present the natural history and benefits of an early diagnosis in such individuals is poorly known. Further, the endoscopic demonstration of the small-intestinal damage required for the diagnosis is unpleasant, expensive and often misleading. New serology-based diagnostic criteria have been suggested but prospective data is lacking. Aims of the present study are to improve the diagnostic yield and accuracy of the current diagnostic methods and to develop novel non-invasive methods and biomarkers for early detection of celiac disease. In addition, the investigators will evaluate natural history of celiac disease in screening-detected asymptomatic children and in those with positive serology but normal histology, and form a large database for future clinical and translational studies. The study and patient collection are to be conducted at the pediatric clinics in Finland and in Romania. All children referred due to suspicion of celiac disease or gluten sensitivity will be asked to participate to the study. Patient samples and clinical information are collected during the routine visits and the study does not include any additional visits or endoscopies. The total duration of the study is 10 years but data will be analyzed on-line.

Official Title
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Improved Diagnostics of Celiac Disease in Children

Conditions
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Celiac Disease, Eosinophilic Esophagitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicion of celiac disease or gluten sensitivity Age below 18 years Exclusion Criteria: Study refusal Age 18 years or more

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 17 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transglutaminase 2 antibodies | Change of the transglutaminase 2 antibody levels on a gluten-free diet | Baseline and after 3 months, 6 months and 1 year on a gluten-free diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum endomysial antibodies | Change of the endomysial antibody levels on a gluten-free diet | Baseline and after 3 months, 6 months and 1 year on a gluten-free diet | 
| Visual Analog Scale | Change in the the subjective perception of health measured by Visual Analog Scale | Baseline and after 3 months, 6 months and 1 year on a gluten-free diet | 
| Dietary compliance | Adherence to the gluten-free diet | After 3 months, 6 months and 1 year on a gluten-free diet | 
| Height | Change of height (centimeters) on a gluten-free diet | Baseline and after 3 months, 6 months and 1 year on a gluten-free diet | 
| Weight | Change of weight (kilograms) on a gluten-free diet | Baseline and after 3 months, 6 months and 1 year on a gluten-free diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac disease, Eosinophilic esophagitis, Endomysial antibodies, Transglutaminase antibodies, Small-bowel