Clinical trial NCT05084937: Celiac Disease in Childhood-Adulthood Transition
Official title: Celiac Disease in Childhood-Adulthood Transition (CeliCAT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Celiac Disease
Celiac Disease in Children
Transition of Care
Follow-up
Diet, Gluten-Free
Keywords: celiac disease
adolescents
transition
follow-up
gluten-free diet
quality of life
health
symptoms
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Kuopio University Hospital
name: Turku University Hospital
name: Seinajoki Central Hospital
name: South Carelia Central Hospital
First posted: 2021-10-20
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Structured transition form is used with 50% of the study patients
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adherence to a gluten-free diet
timeFrame: At the onset of the study
measure: Change in adherence to a gluten-free diet
timeFrame: After 1 and 3 years
measure: Transition readiness
timeFrame: At the onset of the study
measure: Change in transition readiness
timeFrame: After 1 and 3 years
Secondary outcomes:
measure: General health and health concerns
timeFrame: At the onset of the study
measure: Change in general health and health concerns
timeFrame: After 1 and 3 years
measure: Symptoms
timeFrame: At the onset of the study
measure: Change in symptoms
timeFrame: After 1 and 3 years
measure: Quality of life
timeFrame: At the onset of the study
measure: Change in quality of life
timeFrame: After 1 and 3 years
measure: Costs
timeFrame: At the onset of the study
measure: Abnormalities in follow-up laboratory evaluations
timeFrame: At the onset of the study
measure: Abnormalities in physical examination
timeFrame: At the onset of the study
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Tampere Celiac Disease Research Center, Tampere University
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: