Celiac Disease in Childhood-Adulthood Transition

Not Applicable

• Conditions: Celiac Disease; Celiac Disease in Children; Follow-up; Diet, Gluten-Free; Transition of Care
• Interventions: Other: CeliCAT form

• Registration Number: NCT05084937
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study First Submitted: 2021-09-27
• Study First Submitted QC: 2021-10-07
• Study First Posted: 2021-10-20
• Study Start: 2021-11-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured transition	CeliCAT form	With the help of CeliCAT form

Primary Outcome Measures

Name	Time	Method
Change in transition readiness	After 1 and 3 years	Assessed with questionnaire
Transition readiness	At the onset of the study	Assessed with questionnaire
Change in adherence to a gluten-free diet	After 1 and 3 years	Assessed with questionnaire, celiac autoantibodies and urine GIP
Adherence to a gluten-free diet	At the onset of the study	Assessed with questionnaire, celiac autoantibodies and urine GIP

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	After 1 and 3 years	Assessed with questionnaire
Symptoms	At the onset of the study	Assessed with questionnaire
Abnormalities in follow-up laboratory evaluations	At the onset of the study	Assessed with blood sample
Change in general health and health concerns	After 1 and 3 years	Assessed with questionnaire
Change in symptoms	After 1 and 3 years	Assessed with questionnaire
Quality of life	At the onset of the study	Assessed with questionnaire
Costs	At the onset of the study	Assessed with questionnaire
General health and health concerns	At the onset of the study	Assessed with questionnaire
Abnormalities in physical examination	At the onset of the study	Assessed with medical examination

Trial Locations

Locations (5)

Tampere Celiac Disease Research Center, Tampere University; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

South Karelia Central Hospital; 🇫🇮 Lappeenranta, Finland