Celiac DiseaseCeliCATNCT05084937
Celiac Disease in Childhood-Adulthood Transition
A study testing CeliCAT form in people with Celiac Disease and Celiac Disease in Children, run by Tampere University Hospital at 5 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Celiac Disease, Celiac Disease in Children, Transition of Care
- What is being tested?
- CeliCAT form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesFinland
- Study dates
- 1 Nov 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- verified celiac disease diagnosis in childhood (<16 years of age)
- age 13-19 years at recruitment
- Finnish-speaking
- no celiac disease diagnosis
- age 13-19 years at recruitment
- Finnish-speaking
Who cannot join
- disease or condition preventing the completing of the study questionnaire
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Kuopio University Hospital
Kuopio
South Karelia Central Hospital
Lappeenranta
Seinäjoki Central Hospital
Seinäjoki
Tampere Celiac Disease Research Center, Tampere University
Tampere
Turku University Hospital
Turku
About this study
Official title: 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.
Read the 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.
- Conditions
- Celiac Disease, Celiac Disease in Children, Transition of Care, Follow-up, Diet, Gluten-Free
- Being tested
- CeliCAT form
- Keywords
- celiac disease, adolescents, transition, follow-up, gluten-free diet, quality of life, health, symptoms
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeliCAT formOther
Systematic summary to support transition
| Study group | Role | What they receive |
|---|---|---|
| Structured transition | Active comparator | With the help of CeliCAT form Receives: Other: CeliCAT form |
| Routine practices | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to a gluten-free diet
Assessed with questionnaire, celiac autoantibodies and urine GIP
Measured: At the onset of the study
Change in adherence to a gluten-free diet
Assessed with questionnaire, celiac autoantibodies and urine GIP
Measured: After 1 and 3 years
Transition readiness
Assessed with questionnaire
Measured: At the onset of the study
Change in transition readiness
Assessed with questionnaire
Measured: After 1 and 3 years
Secondary outcomes (9)
General health and health concerns
Assessed with questionnaire
Measured: At the onset of the study
Change in general health and health concerns
Assessed with questionnaire
Measured: After 1 and 3 years
Symptoms
Assessed with questionnaire
Measured: At the onset of the study
Change in symptoms
Assessed with questionnaire
Measured: After 1 and 3 years
Quality of life
Assessed with questionnaire
Measured: At the onset of the study
Change in quality of life
Assessed with questionnaire
Measured: After 1 and 3 years
Costs
Assessed with questionnaire
Measured: At the onset of the study
Abnormalities in follow-up laboratory evaluations
Assessed with blood sample
Measured: At the onset of the study
Abnormalities in physical examination
Assessed with medical examination
Measured: At the onset of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Nov 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Structured transition form is used with 50% of the study patients
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Kuopio University Hospital, Turku University Hospital, Seinajoki Central Hospital, South Carelia Central Hospital
- Responsible party
- Principal investigator, Laura Kivelä, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084937
- Sponsor's protocol ID
- R20068
- Acronym
- CeliCAT
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Disease in Childhood-Adulthood Transition (CeliCAT)
- ClinicalTrials.gov ID
- NCT05084937
- Acronym / sponsor ID
- CeliCAT / R20068
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Kuopio University Hospital, Turku University Hospital, Seinajoki Central Hospital, South Carelia Central Hospital
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Structured transition form is used with 50% of the study patients
| Arm | Type | Receives |
|---|---|---|
| Structured transition | Active comparator | Other: CeliCAT formWith the help of CeliCAT form |
| Routine practices | No intervention | – |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- verified celiac disease diagnosis in childhood (<16 years of age)
- age 13-19 years at recruitment
- Finnish-speaking
- no celiac disease diagnosis
- age 13-19 years at recruitment
Key exclusion criteria (1 listed)
- disease or condition preventing the completing of the study questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeliCAT formSystematic summary to support transition | Other | Structured transition |
Primary outcome
Adherence to a gluten-free diet
Time frame: At the onset of the study
Assessed with questionnaire, celiac autoantibodies and urine GIP
Change in adherence to a gluten-free diet
Time frame: After 1 and 3 years
Assessed with questionnaire, celiac autoantibodies and urine GIP
Transition readiness
Time frame: At the onset of the study
Assessed with questionnaire
Change in transition readiness
Time frame: After 1 and 3 years
Assessed with questionnaire
9 secondary outcomes
General health and health concerns
Time frame: At the onset of the study
Change in general health and health concerns
Time frame: After 1 and 3 years
Symptoms
Time frame: At the onset of the study
Change in symptoms
Time frame: After 1 and 3 years
Quality of life
Time frame: At the onset of the study
Change in quality of life
Time frame: After 1 and 3 years
Costs
Time frame: At the onset of the study
Abnormalities in follow-up laboratory evaluations
Time frame: At the onset of the study
Abnormalities in physical examination
Time frame: At the onset of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeliCAT form in people with Celiac Disease and Celiac Disease in Children, run by Tampere University Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to a gluten-free diet (time frame: At the onset of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.