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

N/ANot Yet RecruitingNCT07157137

Medical University of Warsaw140 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

140

Conditions

Celiac Disease in Children Gluten-free Diet

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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).

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.