Celiac Disease in Childhood-Adulthood Transition

NCT ID: NCT05084937

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Structured transition

With the help of CeliCAT form

Group Type: ACTIVE_COMPARATOR

CeliCAT form

Intervention Type: OTHER

Systematic summary to support transition

Routine practices

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CeliCAT form

Systematic summary to support transition

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• verified celiac disease diagnosis in childhood (<16 years of age)
• age 13-19 years at recruitment
• Finnish-speaking

• no celiac disease diagnosis
• age 13-19 years at recruitment
• Finnish-speaking

Exclusion Criteria

• disease or condition preventing the completing of the study questionnaire

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: collaborator

Seinajoki Central Hospital

OTHER

Sponsor Role: collaborator

South Carelia Central Hospital

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laura Kivelä

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kuopio University Hospital

Kuopio, , Finland

South Karelia Central Hospital

Lappeenranta, , Finland

Seinäjoki Central Hospital

Seinäjoki, , Finland

Tampere Celiac Disease Research Center, Tampere University

Tampere, , Finland

Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

R20068

Identifier Type: -

Identifier Source: org_study_id