Celiac Disease in Childhood-Adulthood Transition (CeliCAT)

Tampere University Hospital

Status: Invitation-only

Conditions: Celiac Disease; Follow-up; Celiac Disease in Children; Diet, Gluten-Free; Transition of Care

Treatments: Other: CeliCAT form

Study type: Interventional

Funder types: Other

Identifiers

NCT05084937

R20068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Structured transition

Active Comparator group

Description:

With the help of CeliCAT form

Treatment:

Other: CeliCAT form

Routine practices

No Intervention group