Celiac Disease in Childhood-Adulthood Transition (CeliCAT)

August 11, 2023 updated by: Laura Kivelä, Tampere University Hospital

Celiac Disease in Childhood-Adulthood Transition (CeliCAT)

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.

Study Overview

Status

Enrolling by invitation

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

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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