Celiac Disease in Childhood-Adulthood Transition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CeliCAT form.
- Who it may be relevant to
- Registry conditions: Celiac Disease, Celiac Disease in Children, Transition of Care, Follow-up. Basic parameters: 13 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Celiac Disease in Childhood-Adulthood Transition (CeliCAT)
Overview
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.
Detailed description
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.
Interventions
- Other CeliCAT form
Systematic summary to support transition
Primary outcome measures
- Adherence to a gluten-free diet [Time frame: At the onset of the study]
- Change in adherence to a gluten-free diet [Time frame: After 1 and 3 years]
- Transition readiness [Time frame: At the onset of the study]
- Change in transition readiness [Time frame: After 1 and 3 years]
Secondary outcome measures (9)
- General health and health concerns [Time frame: At the onset of the study]
- Change in general health and health concerns [Time frame: After 1 and 3 years]
- Symptoms [Time frame: At the onset of the study]
- Change in symptoms [Time frame: After 1 and 3 years]
- Quality of life [Time frame: At the onset of the study]
- Change in quality of life [Time frame: After 1 and 3 years]
- Costs [Time frame: At the onset of the study]
- Abnormalities in follow-up laboratory evaluations [Time frame: At the onset of the study]
- Abnormalities in physical examination [Time frame: At the onset of the study]
Eligibility criteria
Inclusion criteria
- verified celiac disease diagnosis in childhood (<16 years of age)
- age 13-19 years at recruitment
- Finnish-speaking
Exclusion criteria
- disease or condition preventing the completing of the study questionnaire
Inclusion criteria for controls
- no celiac disease diagnosis
- age 13-19 years at recruitment
- Finnish-speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Finland · 5 centers
- Kuopio University Hospital — Kuopio
- South Karelia Central Hospital — Lappeenranta
- Seinäjoki Central Hospital — Seinäjoki
- Tampere Celiac Disease Research Center, Tampere University — Tampere
- Turku University Hospital — Turku
Identifiers
NCT: NCT05084937 · R20068