An interventional study of CeliCAT form in Celiac Disease, Celiac Disease in Children and Transition of Care, sponsored by Tampere University Hospital. Enrolling by invitation at 5 sites in Finland. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Supportive care
Aims of this study are to evaluate adolescents with celiac disease during their transition from pediatrics to adult care, and to develop better healthcare follow-up practices.
Celiac disease is one of the most common chronic gastrointestinal diseases affecting 1-3% of population worldwide. It is treated with life-long and strict gluten-free diet. When dietary treatment is successful, prognosis of pediatric patients seems to be excellent whereas ongoing predisposition to gluten may increase the risk even to permanent complications. However, gluten-free diet may cause burden and restrictions in everyday life impairing quality of life. Regular follow-up is recommended to support the treatment and to detect early possible comorbidities and complications, but, in practice, patients are often lost to follow-up. Studies about the significance of follow-up and its optimal implementation are scarce. Pediatric patients form a special group here as they may not even remember the reason for the diagnosis if it was set in early childhood, and the education about the disease and its treatment are often given primarily to the caregivers. Responsibility of the treatment shifts to patients themselves in adolescence at the same time with other significant changes in life and they have more often challenges with gluten-free diet than other patients. Despite this, studies about the transition from pediatrics to adult-care are very few.
This study evaluates 13-19 years old patients diagnosed with celiac disease in childhood (\<16 years of age) and compares them to adolescents without celiac disease in selected variables. Study focuses on healthcare follow-up practices and pilot a CeliCAT transition form in a randomized, controlled study design. The main hypothesis is that structured follow-up and transition of pediatric patients to adult care predicts better health, quality of life and adherence to the dietary treatment later in life. Data is collected with physical examination, questionnaires and with blood and urine samples. Follow-up is arranged at one and three years from the first visit.
333 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 400 is above the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for controls
With the help of CeliCAT form
Other: CeliCAT form
Systematic summary to support transition
Adherence to a gluten-free diet
Assessed with questionnaire, celiac autoantibodies and urine GIP
Time frame: At the onset of the study
Change in adherence to a gluten-free diet
Assessed with questionnaire, celiac autoantibodies and urine GIP
Time frame: After 1 and 3 years
Transition readiness
Assessed with questionnaire
Time frame: At the onset of the study
Change in transition readiness
Assessed with questionnaire
Time frame: After 1 and 3 years
General health and health concerns
Assessed with questionnaire
Time frame: At the onset of the study
Change in general health and health concerns
Assessed with questionnaire
Time frame: After 1 and 3 years
Symptoms
Assessed with questionnaire
Time frame: At the onset of the study
Change in symptoms
Assessed with questionnaire
Time frame: After 1 and 3 years
Quality of life
Assessed with questionnaire
Time frame: At the onset of the study
Change in quality of life
Assessed with questionnaire
Time frame: After 1 and 3 years
Costs
Assessed with questionnaire
Time frame: At the onset of the study
Abnormalities in follow-up laboratory evaluations
Assessed with blood sample
Time frame: At the onset of the study
Abnormalities in physical examination
Assessed with medical examination
Time frame: At the onset of the study
Plan to share: No
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Tampere University Hospital