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

NCT ID: NCT07157137

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-08-31

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.

Conditions

Celiac Disease in Children; Gluten-free Diet

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Aleksandra Banaszkiewicz

MD, PhD, Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CD-PL

Identifier Type: -

Identifier Source: org_study_id