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Enrolling By Invitation
NCT07885735
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Conditions: Celiac Disease in Children, Nutritional Assessment
Sex: All
Ages: 1 Year – 18 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: Ondokuz Mayıs University
Location: Balıkesir Atatürk City Hospital Balıkesir
Summary
The aim is to explain that celiac disease (CD) is an autoimmune, familial disease that develops in genetically predisposed individuals as a result of sensitivity to gluten found in grains and grain products, causing characteristic lesions and malabsorption in the small intestine, and showing clinical improvement with a gluten-free diet. Beyond the gastrointestinal system, the disease affects skeletal muscle health due to malabsorption and malnutrition. Sarcopenia, particularly seen in elderly patients due to decreased muscle mass and strength, can also occur in celiac patients, especially at an early age, due to chronic inflammation, protein malabsorption, and reduced nutrient intake. Therefore, the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends regular evaluation of celiac patients in terms of growth, nutritional status, and muscle health. However, gold standard diagnostic methods such as magnetic resonance imaging (MRI) and computed tomography (CT) are insufficient in clinical practice due to high cost, limited accessibility, portability, and radiation exposure, necessitating alternative methods. Ultrasonography has emerged as a promising method for screening and diagnosing sarcopenia in celiac patients. Because non-invasive, inexpensive, and widely available ultrasonography can increase awareness of sarcopenia, enable early nutritional intervention, and improve clinical and laboratory results in celiac disease. The aim of this study is to investigate the evaluation of nutritional status by measuring muscle mass using routine ultrasonography performed on pediatric patients diagnosed with celiac disease in the Pediatric Gastroenterology units of Balıkesir Atatürk City Hospital and Hitit University. Thus, the aim is to determine the diagnostic accuracy of ultrasound in the evaluation of sarcopenia in celiac patients.
Eligibility Criteria
Inclusion Criteria for Children With Celiac Disease
* Children aged 1-18 years.
* Confirmed diagnosis of celiac disease according to established ESPGHAN diagnostic criteria, based on serological findings with or without duodenal biopsy, as appropriate.
* Availability of clinical, laboratory, anthropometric, and ultrasonographic data required for the study.
* Written informed consent obtained from a parent or legal guardian.
* Age-appropriate assent obtained from the child when applicable.
For the Control Group
Children aged 1-18 years.
No known chronic systemic, gastrointestinal, or neuromuscular disease.
No established diagnosis of celiac disease.
Availability of anthropometric data and standardized ultrasonographic muscle thickness measurements.
Written informed consent obtained from a parent or legal guardian and age-appropriate assent from the child when applicable.
Exclusion Criteria
* Age outside the specified range of 1-18 years.
* Presence of chronic systemic diseases that may affect nutritional status, growth, or muscle thickness, other than celiac disease in the patient group.
* Presence of neuromuscular disorders, musculoskeletal diseases, or physical disabilities that may interfere with muscle thickness measurements.
* Presence of other conditions associated with significant malabsorption or altered nutritional status.
* Inability to obtain reliable ultrasonographic muscle thickness measurements.
* Incomplete essential clinical, anthropometric, or ultrasonographic data required for the primary outcome assessment.
* Failure to obtain written informed consent from a parent or legal guardian or failure to obtain age-appropriate assent when required.
Source: ClinicalTrials.gov (NCT07885735). StuddyBuddy aggregates publicly available trial information.