Celiac Disease in ChildrenCD-PLNCT07157137
Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease
An observational study of Celiac Disease in Children and Gluten-free Diet, run by Medical University of Warsaw.
Trial summary
Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Celiac Disease in Children, Gluten-free Diet
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 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 according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria,
- age from 2 to 18 years of age,
- gluten-free diet use for at least 6 months,
- consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study.
Who cannot join
- under 2 years of age and over 18 years of age,
- immunoglobulin A deficiency,
- inflammatory bowel diseases,
- gastrointestinal bleeding or other active bleeding,
- gastric and/or duodenal ulcers,
- liver failure,
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- heart failure according to the NYHA II-IV scale,
- acute and chronic renal failure,
- cancer,
- after hematopoietic stem cell transplantation,
- 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
Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. The Celiac Dietary Adherence Test (CDAT) and measuring the gluten immunogenic peptide in urine (uGIP) or stool (sGIP) were suggested.
This study aims to evaluate and compare the usefulness of an adapted CDAT, the rapid tests for detecting uGIP and sGIP, for assessing adherence to a GFD in children with CD. Additionally, we will assess these children's nutritional status.
Patients, aged 2-18 years, diagnosed with CD, who have been on a GFD for at least 6 months, will be included. Clinical characteristics and anthropometric measurements will be recorded. The adapted CDAT form will be applied. A single urine and stool samples will be collected immediately, and rapid tests for the detection of GIP will be performed. The serum levels of anti-transglutaminase antibodies (IgA), albumin, ferritin, folate, vitamins B12, A, E, 25-OH vitamin D, blood count and lipid profile will be measured.
- Conditions
- Celiac Disease in Children, Gluten-free Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with coealiac disease. | Patients will undergo anthropometric measurements (body weight, height, and thickness of skin folds over the triceps brachii muscle). Patient data will be collected during the study, including age, gender, date of coeliac disease diagnosis, duration of gluten-free diet and adherence, history of chronic diseases and congenital defects, medications taken, reported allergies, and family history, with particular emphasis on autoimmune diseases. Guardians/parents of patients under 10 years of age and patients over 10 years of age will be asked to complete a validated Celiac Dietary Adherence Test form. For all patients: IgA tissue transglutaminase antibody levels, aminotransferase activity, complete blood count, and ferritin levels will be measured. An additional 5 ml of venous blood will be collected to measure albumin, folic acid, vitamins B12, A, E, 25-OH vitamin D, and a lipid profile. Additionally, a urine and stool sample will be collected to measure gluten immunogenic peptides. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.
Adherence to the gluten-free diet will be assessed based on positive results in the Celiac Dietary Adherence Test questionnaire.
Measured: January 2026 - June 2027
Adherence to the gluten-free diet - the gluten immunogenic peptide in urine.
Adherence to the gluten-free diet will be assessed based on positive results in the gluten immunogenic peptide in urine (uGIP).
Measured: January 2026 - June 2027
Adherence to the gluten-free diet - the gluten immunogenic peptide in stool.
Adherence to the gluten-free diet will be assessed based on positive results in the gluten immunogenic peptide in stool (sGIP).
Measured: January 2026 - June 2027
Comparison of methods
The results of CDAT questionnaire, uGIP and sGIP will be compared to the standard IgA tissue transglutaminase antibody test. Intra-assay agreement will be assessed using the McNemary test. Measures of test quality (sensitivity, specificity, positive and negative predictive values) will be calculated.
Measured: January 2026 - June 2027
Secondary outcomes (1)
The nutritional status of Polish children with coeliac disease
The nutritional status of Polish children with coeliac disease will be assessed by analysing the anthropometric measurements and laboratory tests performed. The results obtained will be compared with data obtained for the general population.
Measured: January 2026 - June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startJan 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 Celiac Disease in ChildrenStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 140 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
- NCT07157137
- Sponsor's protocol ID
- CD-PL
- Acronym
- CD-PL
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 5 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease
- ClinicalTrials.gov ID
- NCT07157137
- Acronym / sponsor ID
- CD-PL / CD-PL
- Conditions
- Celiac Disease in Children, Gluten-free Diet
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Sep 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.
Although a gluten-free diet (GFD) is essential for patients with coeliac disease (CD), many do not follow it strictly. Exposure to gluten causes villous atrophy, can deteriorate nutritional status, and can lead to deficiencies. The ESPGHAN recommends combining multiple methods to assess GFD adherence. The Celiac Dietary Adherence Test (CDAT) and measuring the gluten immunogenic peptide in urine (uGIP) or stool (sGIP) were suggested.
This study aims to evaluate and compare the usefulness of an adapted CDAT, the rapid tests for detecting uGIP and sGIP, for assessing adherence to a GFD in children with CD. Additionally, we will assess these children's nutritional status.
Patients, aged 2-18 years, diagnosed with CD, who have been on a GFD for at least 6 months, will be included. Clinical characteristics and anthropometric measurements will be recorded. The adapted CDAT form will be applied. A single urine and stool samples will be collected immediately, and rapid tests for the detection of GIP will be performed. The serum levels of anti-transglutaminase antibodies (IgA), albumin, ferritin, folate, vitamins B12, A, E, 25-OH vitamin D, blood count and lipid profile will be measured.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with coealiac disease. | – | –Patients will undergo anthropometric measurements (body weight, height, and thickness of skin folds over the triceps brachii muscle). Patient data will be collected during the study, including age, gender, date of coeliac disease diagnosis, duration of gluten-free diet and adherence, history of chronic diseases and congenital defects, medications taken, reported allergies, and family history, with particular emphasis on autoimmune diseases. Guardians/parents of patients under 10 years of age and patients over 10 years of age will be asked to complete a validated Celiac Dietary Adherence Test form. For all patients: IgA tissue transglutaminase antibody levels, aminotransferase activity, complete blood count, and ferritin levels will be measured. An additional 5 ml of venous blood will be collected to measure albumin, folic acid, vitamins B12, A, E, 25-OH vitamin D, and a lipid profile. Additionally, a urine and stool sample will be collected to measure gluten immunogenic peptides. |
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 (4 listed)
- diagnosis of coeliac disease according to the European Society of Pediatric Gastroenterology and Nutrition (ESPGHAN) criteria,
- age from 2 to 18 years of age,
- gluten-free diet use for at least 6 months,
- consent from legal guardians (and the child in case of patients ≥16 years of age) to participate in the study.
Key exclusion criteria (12 listed)
- under 2 years of age and over 18 years of age,
- immunoglobulin A deficiency,
- inflammatory bowel diseases,
- gastrointestinal bleeding or other active bleeding,
- gastric and/or duodenal ulcers,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.
Time frame: January 2026 - June 2027
Adherence to the gluten-free diet will be assessed based on positive results in the Celiac Dietary Adherence Test questionnaire.
Adherence to the gluten-free diet - the gluten immunogenic peptide in urine.
Time frame: January 2026 - June 2027
Adherence to the gluten-free diet will be assessed based on positive results in the gluten immunogenic peptide in urine (uGIP).
Adherence to the gluten-free diet - the gluten immunogenic peptide in stool.
Time frame: January 2026 - June 2027
Adherence to the gluten-free diet will be assessed based on positive results in the gluten immunogenic peptide in stool (sGIP).
Comparison of methods
Time frame: January 2026 - June 2027
The results of CDAT questionnaire, uGIP and sGIP will be compared to the standard IgA tissue transglutaminase antibody test. Intra-assay agreement will be assessed using the McNemary test. Measures of test quality (sensitivity, specificity, positive and negative predictive values) will be calculated.
1 secondary outcome
The nutritional status of Polish children with coeliac disease
Time frame: January 2026 - June 2027
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 5 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 Celiac Disease in Children and Gluten-free Diet, 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 4 inclusion and 12 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 5 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?
Adherence to a gluten-free diet - the Celiac Dietary Adherence Test. (time frame: January 2026 - June 2027). 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 5 Sep 2025.