Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorMedical University of Warsaw

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 1 trial group
Group A: Children with coealiac disease.

Trial outcomes

Primary outcomes

1

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.

Time frame
January 2026 - June 2027
2

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).

Time frame
January 2026 - June 2027
3

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).

Time frame
January 2026 - June 2027
4

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.

Time frame
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.

Time frame
January 2026 - June 2027

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: