About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
under 2 years of age and over 18 years of age,
immunoglobulin A deficiency,
inflammatory bowel diseases,
gastrointestinal bleeding or other active bleeding,
Trial population
Polish children with CD.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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).
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).
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.
Secondary outcomes
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.
Locations
Sponsors and contacts
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