Celiac Disease in Childhood-Adulthood Transition

Celiac Disease Clinical Trial

— CeliCAT  

Official title:

Celiac Disease in Childhood-Adulthood Transition (CeliCAT)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05084937
• Other study ID #: R20068
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• CeliCAT form
Systematic summary to support transition

Locations

Country	Name	City	State
Finland	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

Sponsors (6)

Lead Sponsor	Collaborator
Tampere University Hospital	Kuopio University Hospital, Seinajoki Central Hospital, South Carelia Central Hospital, Tampere University, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to a gluten-free diet	Assessed with questionnaire, celiac autoantibodies and urine GIP	At the onset of the study
Primary	Change in adherence to a gluten-free diet	Assessed with questionnaire, celiac autoantibodies and urine GIP	After 1 and 3 years
Primary	Transition readiness	Assessed with questionnaire	At the onset of the study
Primary	Change in transition readiness	Assessed with questionnaire	After 1 and 3 years
Secondary	General health and health concerns	Assessed with questionnaire	At the onset of the study
Secondary	Change in general health and health concerns	Assessed with questionnaire	After 1 and 3 years
Secondary	Symptoms	Assessed with questionnaire	At the onset of the study
Secondary	Change in symptoms	Assessed with questionnaire	After 1 and 3 years
Secondary	Quality of life	Assessed with questionnaire	At the onset of the study
Secondary	Change in quality of life	Assessed with questionnaire	After 1 and 3 years
Secondary	Costs	Assessed with questionnaire	At the onset of the study
Secondary	Abnormalities in follow-up laboratory evaluations	Assessed with blood sample	At the onset of the study
Secondary	Abnormalities in physical examination	Assessed with medical examination	At the onset of the study