Celiac Disease in ChildrenNCT07885735
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
A study testing performing muscle ultrasonography on patients in people with Celiac Disease in Children and Nutritional Assessment, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Nutritional Assessment
- What is being tested?
- performing muscle ultrasonography on patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound.
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.
Read the detailed description
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..
- Conditions
- Celiac Disease in Children, Nutritional Assessment
- Being tested
- performing muscle ultrasonography on patients
- Keywords
- celiac disease, children, muscle ultrasonography
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performing muscle ultrasonography on patientsDevice
performing muscle ultrasonography on patients
| Study group | Role | What they receive |
|---|---|---|
| Muscle ultrasonography applied to celiac disease patients | Experimental | Muscle ultrasonography applied to healty groups Receives: Device: performing muscle ultrasonography on patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline (single assessment at study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start3 Aug 2026
- Primary completion28 Sep 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Demirbaş, Balikesir Ataturk City Hospital
- Investigators
- fatma demirbaş ar, Principal investigator, Balikesir Ataturk City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885735
- Sponsor's protocol ID
- 2026-194
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data used in publishing the results
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound.
- ClinicalTrials.gov ID
- NCT07885735
- Acronym / sponsor ID
- 2026-194
- Conditions
- Celiac Disease in Children, Nutritional Assessment
- Keywords
- celiac disease, children, muscle ultrasonography
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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..
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle ultrasonography applied to celiac disease patients | Experimental | Device: performing muscle ultrasonography on patientsMuscle ultrasonography applied to healty groups |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| performing muscle ultrasonography on patientsperforming muscle ultrasonography on patients | Device | Muscle ultrasonography applied to celiac disease patients |
Primary outcome
Regional Muscle Thickness Measured by Ultrasonography in Children With Celiac Disease and Healthy Controls
Time frame: At baseline (single assessment at study enrollment)
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.
Association Between Ultrasonographic Muscle Thickness and Anthropometric Z-Scores in Children With Celiac Disease
Time frame: At baseline (single assessment at study enrollment)
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.
Ultrasonographic Muscle Thickness According to Malnutrition Status in Children With Celiac Disease
Time frame: At baseline (single assessment at study enrollment)
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.
Ultrasonographic Muscle Thickness According to Gluten-Free Diet Adherence in Children With Celiac Disease
Time frame: At baseline (single assessment at study enrollment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual patient data used in publishing the results
Related trials for Celiac Disease in Children
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
Enrolling by invitation
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Active, not recruiting
Prevention of Celiac Disease in Skåne
Celiac Disease in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
fatma demirbaş ar principal investigator
Balikesir Ataturk City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing performing muscle ultrasonography on patients in people with Celiac Disease in Children and Nutritional Assessment, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Muscle Thickness Measured by Ultrasonography in Children With Celiac Disease and Healthy Controls (time frame: At baseline (single assessment at study enrollment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.