Coeliac DiseaseCD-PL-CDATNCT07142148
Validation of the CDAT in the Polish Paediatric Population
An observational study of Coeliac Disease and Celiac Disease in Children, run by Medical University of Warsaw.
Trial summary
The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants). The Polish translation will be performed by two native bilingual speakers of Polish and English. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Coeliac Disease, Celiac Disease in Children
- What is being tested?
- CDAT - phase 1 and CDAT - phase 2
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Aug 2027
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Polish children with CD.
Who may be able to join
- diagnosis of coeliac disease (CD) according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria,
- age from 2 to 18 years of age,
- consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study.
Who cannot join
- whose legal guardians did not consent to participate in the study,
- who did not consent to participate in the study (applies to patients ≥ 16 years of age).
About this study
Official title: Validation of the Celiac Dietary Adherence Test in the Polish Paediatric Population
The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants).
The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity.
Read more
In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale [1 = unclear to 5 = very clear]. Questions with a mean score <4.0 will be rephrased and re-evaluated.
Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index.
- Conditions
- Coeliac Disease, Celiac Disease in Children
- Being tested
- CDAT - phase 1, CDAT - phase 2
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDAT - phase 1Diagnostic test
The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants). The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity.
CDAT - phase 2Other
In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale [1 = unclear to 5 = very clear]. Questions with a mean score <4.0 will be rephrased and re-evaluated.
Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of Celiac Dietary Adherence Test (CDAT) in the Polish paediatric population.
The Celiac Dietary Adherence Test (CDAT) questionnaire will be validated in the Polish paediatric population.
Measured: September 2025 - June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Banaszkiewicz, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142148
- Sponsor's protocol ID
- CD-PL-CDAT
- Acronym
- CD-PL-CDAT
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Celiac Dietary Adherence Test in the Polish Paediatric Population
- ClinicalTrials.gov ID
- NCT07142148
- Acronym / sponsor ID
- CD-PL-CDAT / CD-PL-CDAT
- Conditions
- Coeliac Disease, Celiac Disease in Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Aug 2025 (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.
The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants).
The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity.
In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale [1 = unclear to 5 = very clear]. Questions with a mean score <4.0 will be rephrased and re-evaluated.
Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Polish children with CD.
Key inclusion criteria (3 listed)
- diagnosis of coeliac disease (CD) according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria,
- age from 2 to 18 years of age,
- consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study.
Key exclusion criteria (2 listed)
- whose legal guardians did not consent to participate in the study,
- who did not consent to participate in the study (applies to patients ≥ 16 years of age).
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 |
|---|---|---|
| CDAT - phase 1The English version of the Celiac Dietary Adherence Test (CDAT) will be translated into Polish using the "forward-backwards-forward" translation model, with the author's consent (already obtained by the applicants). The Polish translation will be performed by two native bilingual speakers of Polish and English. Both translations will be compared and standardised. The Polish version will then be translated into English by two native bilingual speakers of English who are unfamiliar with the original English version. The translation and original will be compared to clarify discrepancies and ensure conceptual equivalence between the versions. The agreed-upon translation will be culturally adapted, if necessary. The items will be reviewed by five experts, and an I-CVI of at least 0.78 will be considered satisfactory content validity. | Diagnostic test | – |
| CDAT - phase 2In the next step, 10 coeliac disease (CD) patients aged 10 years and older and 10 caregivers/parents of CD patients under 10 years of age will be asked to rate the clarity of each statement on a Likert scale [1 = unclear to 5 = very clear]. Questions with a mean score <4.0 will be rephrased and re-evaluated. Internal consistency analysis using Cronbach's alpha and the mean inter-item correlation (AIC) will be used to assess reliability. Convergent validity will be assessed by comparing scale scores with serological marker levels. Confirmatory factor analysis (CFA) will be conducted, taking into account the SRMR fit index. | Other | – |
Primary outcome
Validation of Celiac Dietary Adherence Test (CDAT) in the Polish paediatric population.
Time frame: September 2025 - June 2027
The Celiac Dietary Adherence Test (CDAT) questionnaire will be validated in the Polish paediatric population.
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 3 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coeliac Disease and Celiac Disease in Children, run by Medical University of Warsaw.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Validation of Celiac Dietary Adherence Test (CDAT) in the Polish paediatric population. (time frame: September 2025 - June 2027). 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 3 Sep 2025.