Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 140
- Primary Endpoint
- Adherence to a gluten-free diet - the Celiac Dietary Adherence Test.
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The nutritional status of Polish children with coeliac disease(January 2026 - June 2027)
Investigators
Aleksandra Banaszkiewicz
MD, PhD, Prof.
Medical University of Warsaw