An interventional study of performing muscle ultrasonography on patients in Celiac Disease in Children and Nutritional Assessment, sponsored by Ondokuz Mayıs University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Diagnostic
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.
Celiac disease (CD) is a chronic, systemic, and immune-mediated disorder that primarily affects the small intestine and is triggered by the consumption of gluten and related prolamins found in wheat, barley, and rye by genetically susceptible individuals (1). CD can present with gastrointestinal and extraintestinal symptoms and may be associated with malabsorption, micronutrient deficiencies, and malnutrition.. The global prevalence of CD is reported to be approximately 1.4% . The only current treatment for CD is a lifelong gluten-free diet.
The pathogenesis of CD involves a complex interaction between genetic predisposition, gluten exposure, environmental factors, and the ort h response. In genetically susceptible individuals, gluten consumption causes mucosal damage in the proximal small intestine, characterized by increased intraepithelial lymphocytes, crypt hyperplasia, and varying degrees of villous atrophy. A reduction in the intestinal absorption surface area can lead to impaired absorption of energy, protein, vitamins, and minerals, thereby contributing to the development of malabsorption and malnutrition. In particular, the coexistence of protein-energy malnutrition and intestinal inflammation can negatively affect the balance between muscle protein synthesis and breakdown, leading to a decrease in muscle mass and muscle strength.
Magnetic resonance imaging (MRI) and computed tomography (CT) are reference imaging methods for assessing muscle mass, as they allow for detailed and objective measurement of muscle tissue. However, high cost, limited accessibility, and-particularly with CT-exposure to ionizing radiation limit the use of these methods for routine and repeated measurements in children. Therefore, reliable, reproducible, low-cost, and noninvasive methods for assessing muscle mass in pediatric patients are needed.
I Muscle ultrasonography is one of the methods available for evaluating muscle tissue in children. Its lack of ionizing radiation, ease of use, low cost, and suitability for repeated measurements make it advantageous in pediatric practice. Ultrasonographic assessment of muscle thickness, cross-sectional area, and echogenicity provides information about muscle size and structure.
The aim of this study was to evaluate muscle thickness using ultrasonography in children with CD and to investigate its associations with anthropometric measurements, clinical and laboratory characteristics, and nutritional status. Thus, the study aimed to demonstrate the feasibility of using muscle ultrasonography as a noninvasive assessment method for identifying the risk associated with malnutrition and reduced muscle mass in CD..
339 studies on the registry are indexed under Celiac Disease; 80 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 207 interventional studies indexed under Celiac Disease.
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Inclusion Criteria for Children With Celiac Disease
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
Muscle ultrasonography applied to healty groups
Device: performing muscle ultrasonography on patients
performing muscle ultrasonography on patients
Regional Muscle Thickness Measured by Ultrasonography in Children With Celiac Disease and Healthy Controls
Regional muscle thickness will be measured in millimeters (mm) using B-mode ultrasonography in children diagnosed with celiac disease and healthy controls. Measurements will include the rectus abdominis, rectus femoris and biceps brachii muscles. Muscle thickness measurements will be recorded for each anatomical region and compared between the two groups.
Time frame: At baseline (single assessment at study enrollment)
Association Between Ultrasonographic Muscle Thickness and Anthropometric Z-Scores in Children With Celiac Disease
the correlations between regional muscle thickness and anthropometric Z-scores will be reported in children with celiac disease. Muscle thickness of the rectus abdominis, rectus femoris, and biceps brachii will be measured in millimeters (mm) using B-mode ultrasonography. Nutritional status will be characterized using weight-for-age, height-for-age, and BMI-for-age Z-scores calculated from age-appropriate growth references. Associations will be reported as correlation coefficients (r or rho), with corresponding p-values.
Time frame: At baseline (single assessment at study enrollment)
Ultrasonographic Muscle Thickness According to Malnutrition Status in Children With Celiac Disease
Regional muscle thickness will be measured in millimeters (mm) using B-mode ultrasonography in children with celiac disease. Measurements of the rectus abdominis, rectus femoris, and biceps brachii muscles will be compared between children with and without malnutrition. Malnutrition status will be classified according to predefined anthropometric Z-score criteria. Muscle thickness measurements will be reported separately for each group.
Time frame: At baseline (single assessment at study enrollment)
Ultrasonographic Muscle Thickness According to Gluten-Free Diet Adherence in Children With Celiac Disease
Regional muscle thickness will be measured in millimeters (mm) using B-mode ultrasonography in children with celiac disease. Measurements of the rectus abdominis, rectus femoris, and biceps brachii muscles will be compared between patients classified as adherent and non-adherent to a gluten-free diet. Dietary adherence will be determined according to the predefined assessment criteria in the study protocol. Muscle thickness measurements will be reported separately for each group.
Time frame: At baseline (single assessment at study enrollment)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual patient data used in publishing the results
Supporting information: Clinical study report
Time frame: "The period starting 3 months after the results are published and ending 1 year later."
Access criteria: types of analyses suitable for data sharing and statistical methods used for these analyses
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