- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084937
Celiac Disease in Childhood-Adulthood Transition (CeliCAT)
Celiac Disease in Childhood-Adulthood Transition (CeliCAT)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kuopio, Finland
- Kuopio University Hospital
-
Lappeenranta, Finland
- South Karelia Central Hospital
-
Seinäjoki, Finland
- Seinajoki Central Hospital
-
Tampere, Finland
- Tampere Celiac Disease Research Center, Tampere University
-
Turku, Finland
- Turku University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Structured transition
With the help of CeliCAT form
|
Systematic summary to support transition
|
No Intervention: Routine practices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to a gluten-free diet
Time Frame: At the onset of the study
|
Assessed with questionnaire, celiac autoantibodies and urine GIP
|
At the onset of the study
|
Change in adherence to a gluten-free diet
Time Frame: After 1 and 3 years
|
Assessed with questionnaire, celiac autoantibodies and urine GIP
|
After 1 and 3 years
|
Transition readiness
Time Frame: At the onset of the study
|
Assessed with questionnaire
|
At the onset of the study
|
Change in transition readiness
Time Frame: After 1 and 3 years
|
Assessed with questionnaire
|
After 1 and 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General health and health concerns
Time Frame: At the onset of the study
|
Assessed with questionnaire
|
At the onset of the study
|
Change in general health and health concerns
Time Frame: After 1 and 3 years
|
Assessed with questionnaire
|
After 1 and 3 years
|
Symptoms
Time Frame: At the onset of the study
|
Assessed with questionnaire
|
At the onset of the study
|
Change in symptoms
Time Frame: After 1 and 3 years
|
Assessed with questionnaire
|
After 1 and 3 years
|
Quality of life
Time Frame: At the onset of the study
|
Assessed with questionnaire
|
At the onset of the study
|
Change in quality of life
Time Frame: After 1 and 3 years
|
Assessed with questionnaire
|
After 1 and 3 years
|
Costs
Time Frame: At the onset of the study
|
Assessed with questionnaire
|
At the onset of the study
|
Abnormalities in follow-up laboratory evaluations
Time Frame: At the onset of the study
|
Assessed with blood sample
|
At the onset of the study
|
Abnormalities in physical examination
Time Frame: At the onset of the study
|
Assessed with medical examination
|
At the onset of the study
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R20068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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