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NCT Number: NCT07157137

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

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.

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Key information

Conditions

Celiac Disease in Children Gluten-free Diet

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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

  1. The nutritional status of Polish children with coeliac disease

    Time frame: January 2026 - June 2027

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: CD-PL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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