Status:
NOT_YET_RECRUITING
Assessment of the Adherence to a Gluten-free Diet and Nutritional Status of Paediatric Patients With Coeliac Disease
Lead Sponsor:
Medical University of Warsaw
Conditions:
Celiac Disease in Children
Gluten-free Diet
Eligibility:
All Genders
2-18 years
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, an...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07157137
Start Date
January 1 2026
End Date
August 1 2027
Last Update
September 5 2025
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