An observational study in Celiac Disease in Children and Celiac Disease in Adolescents, sponsored by Inonu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Inonu University · Observational
Among 13 studies in Celiac Disease with a site in Turkey — 3 open to participants now, 4 under way, none of them phase 3. Celiac Disease · Turkey.
Among the 13 studies in Celiac Disease with a site in Turkey, this one is one of 3 that started in 2026, is one of 6 observational ones, and was the 10th registered.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 82 is below the median of 185 across 134 observational studies indexed under Celiac Disease.
Browse Celiac Disease studies →3 of the 13 studies in Celiac Disease with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 48 Celiac Disease studies recruiting now, 24 (50%) set no upper age limit and 19 (40%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.
This study: 8 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 3 started in 2026.
Median enrollment 54 across the 7 interventional studies, 56 across the 6 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
1 of 13 have an industry lead sponsor. The 10 most frequent:
Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.
Inonu University has 1 study filed under Celiac Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Celiac Disease with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07750795Bahçeşehir UniversityNutrition and Physical Activity Education in Children With Celiac Disease | 2027-01-01 |
| NCT07382999Inonu UniversityEffect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease | 2027-01-15 |
Among the 13 studies in Celiac Disease with a site in Turkey, from their registry updates:
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
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with celiac disease who comply with the currently recognized sole treatment option-a strict gluten-free diet-will be included.
Patients with a confirmed diagnosis of celiac disease who are non-compliant with a gluten-free diet will be included.
Healthy children who have not been diagnosed with celiac disease will be included.
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.
Time frame: baseline one assestmeant
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline one assestmeant
Plan to share: 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.
Started Feb 2026 (actual). Primary completion is estimated for Jan 2027, 11 months after the start.
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