Celiac Disease in ChildrenNCT07382999
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
An observational study of Celiac Disease in Children and Celiac Disease in Adolescents, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this cross-sectional observational study is to comprehensively examine the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Celiac Disease in Adolescents
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2026to 15 Jan 2027
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study will include adolescents aged 8-18 years with a diagnosis of celiac disease, as well as healthy control participants from the same age group. The celiac disease group will comprise individuals who are both adherent and non-adherent to a gluten-free diet. Healthy controls will be selected from volunteers with no history of chronic neurological, psychiatric, or gastroenterological diseases.
Who may be able to join
- Participants aged between 8 and 18 years with a serologically confirmed diagnosis of celiac disease
- Who have been followed for at least six months after diagnosisn
- For whom written informed consent has been obtained from both the participant and their parent/legal guardian, will be included in the study.
- The healthy control group will consist of individuals in the same age range with no history of chronic neurological, psychiatric, or gastroenterological diseases.
Who cannot join
- Will include the presence of an acute infection or systemic disease
- Diagnosed neurological disorders (such as epilepsy or cerebral palsy);
- A history of severe psychiatric disorders; conditions that may interfere with test administration, including visual, hearing, or ambulatory impairments
- Initiation of psychotropic medication or changes in the current dosage within the past four weeks; the presence of unstable metabolic or endocrine disorders
- Failure to obtain the required informed consent for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya
Melisa İLHAN, Baş Araştırmacı, +905539712295, melisailhan09@gmail.com
Fatma İlknur VAROL, +905551063344, ilknur.varol@inonu.edu.tr
About this study
The aim of this cross-sectional observational study is to comprehensively examine the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. In this context, dual-task gait performance, cognitive processing speed and attention, working memory and executive functions, muscle strength, quality of life, and fatigue levels of individuals with celiac disease who are adherent or non-adherent to a gluten-free diet will be compared with those of healthy peers. In addition, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be taken into account to evaluate the unique effects of diet adherence on neurocognitive and functional outcomes. All assessments will be conducted in accordance with a predefined standardized protocol. The order of measurement instruments will be randomized to minimize potential bias. Inclusion criteria will consist of being between 8 and 18 years of age, having a celiac disease diagnosis confirmed by serology, being followed with this diagnosis for at least six months, and obtaining written informed consent from both the participant and their parent/guardian. For the healthy control group, participants must be within the same age range and have no history of chronic neurological, psychiatric, or gastroenterological conditions. Data analysis will be performed using SPSS
Read the detailed description
Celiac disease (CD) is an immune-mediated enteropathy triggered by the ingestion of gluten, a protein found in wheat, rye, and barley. With a global prevalence of approximately 1%, it is among the most common autoimmune disorders worldwide. Currently, the only accepted treatment is lifelong adherence to a strict gluten-free diet (GFD). It is now well recognized that CD is associated not only with varying degrees of small intestinal inflammation but also with a wide range of gastrointestinal and extraintestinal manifestations, and it may even be present in asymptomatic individuals. Common extraintestinal manifestations include abnormal liver enzymes, arthralgia/arthritis, alopecia, fatigue, headache, anemia, oral ulcers, myalgia, skin rashes, neuropathy, short stature, delayed puberty, osteoporosis, and infertility. The clinical diagnosis of CD is based on histological evaluation of small intestinal biopsies. Serological tests such as immunoglobulin A (IgA) anti-tissue transglutaminase antibodies and endomysial antibodies (EMA; IgA) may be useful in supporting the diagnosis. Several theories suggest that the globalization and spread of "incorrect" or "excessive" versions of the Mediterranean diet, characterized by very high gluten consumption (up to 20 g/day), may have contributed to the increasing prevalence and incidence of CD. In addition, gluten quality may also play a role. The production of new cereal variants for technological purposes in recent years may have influenced the observed rise in CD diagnoses. Except in regions with low frequencies of CD-predisposing genes and low gluten consumption (such as sub-Saharan Africa and Japan), CD prevalence is higher among first-degree relatives of affected individuals (10-15%) and in other high-risk groups, particularly patients with Down syndrome, type 1 diabetes, or IgA deficiency. In addition to genetic susceptibility and gluten exposure, loss of intestinal barrier function, gluten-triggered proinflammatory innate immune responses, inappropriate adaptive immune responses, and gut microbiome imbalance appear to constitute the fundamental components of CD autoimmunity. An abnormal immune response to gluten in CD classically leads to gastrointestinal symptoms such as abdominal pain, diarrhea, constipation, bloating, and weight loss. CD is now considered a multisystem disorder that affects not only the gastrointestinal tract but also the central nervous system, and has been associated with impairments in attention, short- and long-term memory, and executive function, commonly referred to as "brain fog." Dual-task (DT) gait is thought to involve higher-order cognitive processes that control and regulate behavior, including executive function, gait control, and attentional allocation. This process requires activation of multiple cortical regions, such as the prefrontal cortex (PFC), primary motor cortex, supplementary motor cortex, and somatosensory motor cortex. In addition to cortical activation, network efficiency and functional connectivity among various cortical regions, including the PFC and sensorimotor cortices, have been identified as important contributors to the cortical processes involved in DT gait. The aim of this study is to comprehensively investigate the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. Accordingly, dual-task gait performance, cognitive processing speed and attentional functions, working memory and executive functions, muscle strength, quality of life, and fatigue levels of GFD-adherent and non-adherent individuals with CD will be compared with those of healthy peers. Furthermore, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be considered to evaluate the specific effects of dietary adherence on neurocognitive and functional outcomes.
- Keywords
- Celiac, Cognitive function, 10 MWT, TMT A-B
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Celiac patients who adhere to a gluten-free diet | Patients with celiac disease who comply with the currently recognized sole treatment option-a strict gluten-free diet-will be included. | |
| Celiac patients who are non-compliant with a gluten-free diet | Patients with a confirmed diagnosis of celiac disease who are non-compliant with a gluten-free diet will be included. | |
| Healthy children without a diagnosis of celiac disease | Healthy children who have not been diagnosed with celiac disease will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task 10-Meter Walk Test
Following the administration of the 10-Meter Walk Test (10MWT), participants aged 6-11 years will be instructed to verbally name as many animals as they know until they are asked to stop during the test. For participants aged 12-18 years, the serial sevens task (counting backward by sevens starting from 100) will be administered concurrently with the 10MWT.
Measured: baseline one assestmeant
Secondary outcomes (9)
10-meter walk test
A straight 10-meter walkway is used in the study; however, a 2-meter acceleration zone at the beginning and a 2-meter deceleration zone at the end of the walkway are provided. The stopwatch is started after the participant has walked the initial 2 meters and stopped before the final 2 meters. Participants are instructed to walk at their self-selected, natural, and comfortable walking speed. Walking time is recorded in seconds.
Measured: Baseline one assestmeant
Timed Up And Go
Participants are instructed to stand up from a seated position, walk a distance of 3 meters, turn around a cone, return to the chair, and sit down again. The test performance is timed using a stopwatch and recorded in seconds.
Measured: Baseline one assestmeant
Digit Span Test
The Digit Span Test (DST) will be administered via a mobile application, with the forward test performed by progressively increasing the sequence length. The score generated by the application will be recorded.
Measured: Baseline one assestmeant
Trail Making Test
The mobile application version of the Trail Making Test (TMT) will be used. In Part A, numbers displayed within circles are arranged in ascending order. In Part B, both numbers and letters are presented, and participants are required to connect them in an alternating ascending sequence. Task completion time will be recorded as the outcome measure.
Measured: Baseline one assestmeant
Tap Fast
To assess participants' reaction times, the Tap Fast mobile application will be utilized. Participants will be instructed to tap the screen as quickly as possible, touching as many targets as they can within 15 seconds. The score obtained by the participant will be recorded.
Measured: Baseline one assestmeant
The Pediatric Quality of Life Inventory (PedsQL)
The Pediatric Quality of Life Inventory (PedsQL) will be used to assess participants' health-related quality of life. It is a brief instrument evaluating five domains: physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning. The PedsQL is applicable to children and adolescents aged 2-18 years and includes both child self-report and parent proxy-report forms. Items are rated on a 5-point Likert scale (0-4), with higher scores indicating better quality of life.
Measured: Baseline one assestmeant
The Pediatric Fatigue Scale
The Pediatric Fatigue Scale will be used to assess fatigue. The scale can be administered in both child self-report and parent proxy-report forms and is applicable to children and adolescents aged 2-18 years. It comprises three subscales-general fatigue, cognitive fatigue, and sleep/rest fatigue-consisting of a total of 18 items. The scale is particularly valuable for understanding the impact of chronic diseases on daily functioning and psychosocial domains. The Pediatric Fatigue Scale provides a reliable assessment of both the physical and cognitive dimensions of fatigue. Items are rated on a 5-point Likert scale (0-4), with higher scores indicating better functional capacity.
Measured: Baseline one assestmeant
The Physical Activity Questionnaire for Children (PAQ-C) The Physical Activity Questionnaire for Adolescents (PAQ-A)
The Physical Activity Questionnaire for Children (PAQ-C) is a 9-item, 5-point Likert-type self-report measure used to assess moderate-to-vigorous physical activity levels over the previous seven days in children aged 8-14 years. The questionnaire includes items related to sports participation, school-time and out-of-school activities, physical activity during lunch breaks, and evening physical activities. Higher scores indicate better levels of physical activity.
The Physical Activity Questionnaire for Adolescents (PAQ-A) is a 9-item, 5-point Likert-type measure designed to assess moderate-to-vigorous physical activity performed during a typical week by adolescents aged 14-18 years. While similar in structure to the PAQ-C, the PAQ-A is adapted to better reflect adolescents' daily routines, including active transportation to school, after-school activities, and weekend physical activities. Higher scores indicate better levels of physical activity.
Measured: Baseline one assestmeant
The Pediatric Sleep Questionnaire (PSQ)
The Pediatric Sleep Questionnaire (PSQ) is used to evaluate sleep-related problems and to assess reductions in daytime functioning associated with sleep disorders. It is a parent-reported questionnaire administered to children aged 2-18 years. Section A assesses nighttime and sleep-related behaviors, Section B evaluates daytime behaviors and potential problems, and Section C consists of six items assessing attention deficit and hyperactivity symptoms. Responses to Sections A and B are recorded as "Yes," "No," or "Don't know." Items in Section C are rated on a 4-point Likert scale. For scoring purposes, responses marked as 0 or 1 are recoded as 0, whereas responses marked as 2 or 3 are recoded as 1.
In addition, open-ended questions are included to explore the qualitative aspects of sleep problems. A total of 22 items are used in the scoring of the questionnaire.
Measured: Baseline one assestmeant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start12 Feb 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynal Yasacı, Inonu University
- Investigators
- Zeynal YASACI, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382999
- Sponsor's protocol ID
- 1002
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be securely stored by the investigators and may be shared with authorized personnel if deemed necessary, in accordance with applicable privacy regulations.
Publications
Oner P, Barut Y, Oner O, Uneri OS, Bodur S, Turgut S, Munir KM. [Reliability and validity of Turkish translation of the pediatric sleep questionnaire]. Klinik Psikofarmakol Bulteni. 2009;19(4):382-395. Turkish.
PubMed 28804251Janz KF, Lutuchy EM, Wenthe P, Levy SM. Measuring activity in children and adolescents using self-report: PAQ-C and PAQ-A. Med Sci Sports Exerc. 2008 Apr;40(4):767-72. doi: 10.1249/MSS.0b013e3181620ed1.
PubMed 18317366Varni JW, Burwinkle TM, Szer IS. The PedsQL Multidimensional Fatigue Scale in pediatric rheumatology: reliability and validity. J Rheumatol. 2004 Dec;31(12):2494-500.
PubMed 15570657Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Benton MJ, Spicher JM, Silva-Smith AL. Validity and reliability of handgrip dynamometry in older adults: A comparison of two widely used dynamometers. PLoS One. 2022 Jun 21;17(6):e0270132. doi: 10.1371/journal.pone.0270132. eCollection 2022.
PubMed 35727792Candiri B, Ramazanoglu E, Talu B, Tecellioglu M. The relationship between cognitive function and functional capacity, and cognitive reserve and reaction time in patients with multiple sclerosis. Arq Neuropsiquiatr. 2024 Sep;82(9):1-9. doi: 10.1055/s-0044-1788273. Epub 2024 Aug 26.
PubMed 39187267Şanlı AF, Ersöz Hüseyinsinoğlu B, Bilgiç B, Hanağası HA. Parkinson Hastalarında Algılanan ve Gerçek-Zamanlı Çift-Görev Performansının Farklı Motor-Kognitif Çift-Görev Eşleşmeleri Altında İncelenmesi. Hacettepe University Faculty of Health Sciences Journal. 2025;12(2):516-28.
Hosoi Y, Kamimoto T, Sakai K, Yamada M, Kawakami M. Estimation of minimal detectable change in the 10-meter walking test for patients with stroke: a study stratified by gait speed. Front Neurol. 2023 Jul 19;14:1219505. doi: 10.3389/fneur.2023.1219505. eCollection 2023.
PubMed 37538254Tendolkar P, Ibironke O, Marchesi G, De Luca A, Squeri V, Nolan KJ, Pilkar R, Karunakaran KK. Relationship between Timed Up and Go performance and quantitative biomechanical measures of balance. Front Rehabil Sci. 2024 Mar 19;5:1220427. doi: 10.3389/fresc.2024.1220427. eCollection 2024.
PubMed 38566622Ding Q, Ou Z, Yao S, Wu C, Chen J, Shen J, Lan Y, Xu G. Cortical activation and brain network efficiency during dual tasks: An fNIRS study. Neuroimage. 2024 Apr 1;289:120545. doi: 10.1016/j.neuroimage.2024.120545. Epub 2024 Feb 16.
PubMed 38367652Croall ID, Tooth C, Venneri A, Poyser C, Sanders DS, Hoggard N, Hadjivassiliou M. Cognitive Impairment in Coeliac Disease with Respect to Disease Duration and Gluten-Free Diet Adherence: A Pilot Study. Nutrients. 2020 Jul 8;12(7):2028. doi: 10.3390/nu12072028.
PubMed 32650524Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, Fasano A. Celiac disease: a comprehensive current review. BMC Med. 2019 Jul 23;17(1):142. doi: 10.1186/s12916-019-1380-z.
PubMed 31331324De Re V, Magris R, Cannizzaro R. New Insights into the Pathogenesis of Celiac Disease. Front Med (Lausanne). 2017 Aug 31;4:137. doi: 10.3389/fmed.2017.00137. eCollection 2017.
PubMed 28913337Meyer S, Rosenblum S. Examining core self-management skills among adolescents with celiac disease. J Health Psychol. 2021 Nov;26(13):2592-2602. doi: 10.1177/1359105320922304. Epub 2020 May 22.
PubMed 32441135
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
- ClinicalTrials.gov ID
- NCT07382999
- Acronym / sponsor ID
- 1002
- Keywords
- Celiac, Cognitive function, 10 MWT, TMT A-B
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 3 Feb 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 of this cross-sectional observational study is to comprehensively examine the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. In this context, dual-task gait performance, cognitive processing speed and attention, working memory and executive functions, muscle strength, quality of life, and fatigue levels of individuals with celiac disease who are adherent or non-adherent to a gluten-free diet will be compared with those of healthy peers. In addition, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be taken into account to evaluate the unique effects of diet adherence on neurocognitive and functional outcomes. All assessments will be conducted in accordance with a predefined standardized protocol. The order of measurement instruments will be randomized to minimize potential bias. Inclusion criteria will consist of being between 8 and 18 years of age, having a celiac disease diagnosis confirmed by serology, being followed with this diagnosis for at least six months, and obtaining written informed consent from both the participant and their parent/guardian. For the healthy control group, participants must be within the same age range and have no history of chronic neurological, psychiatric, or gastroenterological conditions. Data analysis will be performed using SPSS
Detailed description
Celiac disease (CD) is an immune-mediated enteropathy triggered by the ingestion of gluten, a protein found in wheat, rye, and barley. With a global prevalence of approximately 1%, it is among the most common autoimmune disorders worldwide. Currently, the only accepted treatment is lifelong adherence to a strict gluten-free diet (GFD). It is now well recognized that CD is associated not only with varying degrees of small intestinal inflammation but also with a wide range of gastrointestinal and extraintestinal manifestations, and it may even be present in asymptomatic individuals. Common extraintestinal manifestations include abnormal liver enzymes, arthralgia/arthritis, alopecia, fatigue, headache, anemia, oral ulcers, myalgia, skin rashes, neuropathy, short stature, delayed puberty, osteoporosis, and infertility. The clinical diagnosis of CD is based on histological evaluation of small intestinal biopsies. Serological tests such as immunoglobulin A (IgA) anti-tissue transglutaminase antibodies and endomysial antibodies (EMA; IgA) may be useful in supporting the diagnosis. Several theories suggest that the globalization and spread of "incorrect" or "excessive" versions of the Mediterranean diet, characterized by very high gluten consumption (up to 20 g/day), may have contributed to the increasing prevalence and incidence of CD. In addition, gluten quality may also play a role. The production of new cereal variants for technological purposes in recent years may have influenced the observed rise in CD diagnoses. Except in regions with low frequencies of CD-predisposing genes and low gluten consumption (such as sub-Saharan Africa and Japan), CD prevalence is higher among first-degree relatives of affected individuals (10-15%) and in other high-risk groups, particularly patients with Down syndrome, type 1 diabetes, or IgA deficiency. In addition to genetic susceptibility and gluten exposure, loss of intestinal barrier function, gluten-triggered proinflammatory innate immune responses, inappropriate adaptive immune responses, and gut microbiome imbalance appear to constitute the fundamental components of CD autoimmunity. An abnormal immune response to gluten in CD classically leads to gastrointestinal symptoms such as abdominal pain, diarrhea, constipation, bloating, and weight loss. CD is now considered a multisystem disorder that affects not only the gastrointestinal tract but also the central nervous system, and has been associated with impairments in attention, short- and long-term memory, and executive function, commonly referred to as "brain fog." Dual-task (DT) gait is thought to involve higher-order cognitive processes that control and regulate behavior, including executive function, gait control, and attentional allocation. This process requires activation of multiple cortical regions, such as the prefrontal cortex (PFC), primary motor cortex, supplementary motor cortex, and somatosensory motor cortex. In addition to cortical activation, network efficiency and functional connectivity among various cortical regions, including the PFC and sensorimotor cortices, have been identified as important contributors to the cortical processes involved in DT gait. The aim of this study is to comprehensively investigate the effects of adherence to a gluten-free diet on cognitive, motor, and psychosocial functions in adolescents aged 8-18 years diagnosed with celiac disease. Accordingly, dual-task gait performance, cognitive processing speed and attentional functions, working memory and executive functions, muscle strength, quality of life, and fatigue levels of GFD-adherent and non-adherent individuals with CD will be compared with those of healthy peers. Furthermore, sleep patterns, pubertal development, socioeconomic indicators, and serological markers will be considered to evaluate the specific effects of dietary adherence on neurocognitive and functional outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Celiac patients who adhere to a gluten-free diet | – | –Patients with celiac disease who comply with the currently recognized sole treatment option-a strict gluten-free diet-will be included. |
| Celiac patients who are non-compliant with a gluten-free diet | – | –Patients with a confirmed diagnosis of celiac disease who are non-compliant with a gluten-free diet will be included. |
| Healthy children without a diagnosis of celiac disease | – | –Healthy children who have not been diagnosed with celiac disease will be included. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will include adolescents aged 8-18 years with a diagnosis of celiac disease, as well as healthy control participants from the same age group. The celiac disease group will comprise individuals who are both adherent and non-adherent to a gluten-free diet. Healthy controls will be selected from volunteers with no history of chronic neurological, psychiatric, or gastroenterological diseases.
Key inclusion criteria (4 listed)
- Participants aged between 8 and 18 years with a serologically confirmed diagnosis of celiac disease
- Who have been followed for at least six months after diagnosisn
- For whom written informed consent has been obtained from both the participant and their parent/legal guardian, will be included in the study.
- The healthy control group will consist of individuals in the same age range with no history of chronic neurological, psychiatric, or gastroenterological diseases.
Key exclusion criteria (5 listed)
- Will include the presence of an acute infection or systemic disease
- Diagnosed neurological disorders (such as epilepsy or cerebral palsy);
- A history of severe psychiatric disorders; conditions that may interfere with test administration, including visual, hearing, or ambulatory impairments
- Initiation of psychotropic medication or changes in the current dosage within the past four weeks; the presence of unstable metabolic or endocrine disorders
- Failure to obtain the required informed consent for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dual-task 10-Meter Walk Test
Time frame: baseline one assestmeant
Following the administration of the 10-Meter Walk Test (10MWT), participants aged 6-11 years will be instructed to verbally name as many animals as they know until they are asked to stop during the test. For participants aged 12-18 years, the serial sevens task (counting backward by sevens starting from 100) will be administered concurrently with the 10MWT.
9 secondary outcomes
10-meter walk test
Time frame: Baseline one assestmeant
Timed Up And Go
Time frame: Baseline one assestmeant
Digit Span Test
Time frame: Baseline one assestmeant
Trail Making Test
Time frame: Baseline one assestmeant
Tap Fast
Time frame: Baseline one assestmeant
The Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline one assestmeant
The Pediatric Fatigue Scale
Time frame: Baseline one assestmeant
The Physical Activity Questionnaire for Children (PAQ-C) The Physical Activity Questionnaire for Adolescents (PAQ-A)
Time frame: Baseline one assestmeant
The Pediatric Sleep Questionnaire (PSQ)
Time frame: Baseline one assestmeant
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 9 Sep 2026.
- Background: PubMed 28804251Oner P, Barut Y, Oner O, Uneri OS, Bodur S, Turgut S, Munir KM. [Reliability and validity of Turkish translation of the pediatric sleep questionnaire]. Klinik Psikofarmakol Bulteni. 2009;19(4):382-395. Turkish.
- Background: PubMed 18317366Janz KF, Lutuchy EM, Wenthe P, Levy SM. Measuring activity in children and adolescents using self-report: PAQ-C and PAQ-A. Med Sci Sports Exerc. 2008 Apr;40(4):767-72. doi: 10.1249/MSS.0b013e3181620ed1.
- Background: PubMed 15570657Varni JW, Burwinkle TM, Szer IS. The PedsQL Multidimensional Fatigue Scale in pediatric rheumatology: reliability and validity. J Rheumatol. 2004 Dec;31(12):2494-500.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 35727792Benton MJ, Spicher JM, Silva-Smith AL. Validity and reliability of handgrip dynamometry in older adults: A comparison of two widely used dynamometers. PLoS One. 2022 Jun 21;17(6):e0270132. doi: 10.1371/journal.pone.0270132. eCollection 2022.
- Background: PubMed 39187267Candiri B, Ramazanoglu E, Talu B, Tecellioglu M. The relationship between cognitive function and functional capacity, and cognitive reserve and reaction time in patients with multiple sclerosis. Arq Neuropsiquiatr. 2024 Sep;82(9):1-9. doi: 10.1055/s-0044-1788273. Epub 2024 Aug 26.
- BackgroundŞanlı AF, Ersöz Hüseyinsinoğlu B, Bilgiç B, Hanağası HA. Parkinson Hastalarında Algılanan ve Gerçek-Zamanlı Çift-Görev Performansının Farklı Motor-Kognitif Çift-Görev Eşleşmeleri Altında İncelenmesi. Hacettepe University Faculty of Health Sciences Journal. 2025;12(2):516-28.
- Background: PubMed 37538254Hosoi Y, Kamimoto T, Sakai K, Yamada M, Kawakami M. Estimation of minimal detectable change in the 10-meter walking test for patients with stroke: a study stratified by gait speed. Front Neurol. 2023 Jul 19;14:1219505. doi: 10.3389/fneur.2023.1219505. eCollection 2023.
- Background: PubMed 38566622Tendolkar P, Ibironke O, Marchesi G, De Luca A, Squeri V, Nolan KJ, Pilkar R, Karunakaran KK. Relationship between Timed Up and Go performance and quantitative biomechanical measures of balance. Front Rehabil Sci. 2024 Mar 19;5:1220427. doi: 10.3389/fresc.2024.1220427. eCollection 2024.
- Background: PubMed 38367652Ding Q, Ou Z, Yao S, Wu C, Chen J, Shen J, Lan Y, Xu G. Cortical activation and brain network efficiency during dual tasks: An fNIRS study. Neuroimage. 2024 Apr 1;289:120545. doi: 10.1016/j.neuroimage.2024.120545. Epub 2024 Feb 16.
- Background: PubMed 32650524Croall ID, Tooth C, Venneri A, Poyser C, Sanders DS, Hoggard N, Hadjivassiliou M. Cognitive Impairment in Coeliac Disease with Respect to Disease Duration and Gluten-Free Diet Adherence: A Pilot Study. Nutrients. 2020 Jul 8;12(7):2028. doi: 10.3390/nu12072028.
- Background: PubMed 31331324Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, Fasano A. Celiac disease: a comprehensive current review. BMC Med. 2019 Jul 23;17(1):142. doi: 10.1186/s12916-019-1380-z.
- Individual participant dataSharing planned: No. Participant data will be securely stored by the investigators and may be shared with authorized personnel if deemed necessary, in accordance with applicable privacy regulations.
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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.
Zeynal YASACI principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children and Celiac Disease in Adolescents, run by Inonu 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 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?
Contact Melisa İLHAN (+905539712295, melisailhan09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task 10-Meter Walk Test (time frame: baseline one assestmeant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07382999, which also lists 14 linked publications.
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 9 Sep 2026.