Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
NCT04593251
Celiac Disease, Digestive System Diseases
Brussels, Belgium
View Trial DetailsNCT Number: NCT02072590
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.
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Notify Me0 year–17 year
All sexes
Observational
Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital, Tampere, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Change of the transglutaminase 2 antibody levels on a gluten-free diet
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Change of the endomysial antibody levels on a gluten-free diet
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Change in the the subjective perception of health measured by Visual Analog Scale
Time frame: After 3 months, 6 months and 1 year on a gluten-free diet
Adherence to the gluten-free diet
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Change of height (centimeters) on a gluten-free diet
Time frame: Baseline and after 3 months, 6 months and 1 year on a gluten-free diet
Change of weight (kilograms) on a gluten-free diet
Tampere University Hospital
Other
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