Celiac Disease in ChildrenNCT07436884
Safe and Secure Gluten Free Diet
A study testing Dietary assesment for children with celiac disease in people with Celiac Disease in Children and Nutrition, Healthy, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
The only treatment for celiac disease (CD) consists of following a strict lifelong gluten-free diet, which may lead to potential dietary imbalances and associated diseases. Although individualized dietary counseling should be mandatory for people with celiac disease, they often do not receive this information, and… Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Nutrition, Healthy, Quality of Life
- What is being tested?
- Dietary assesment for children with celiac disease
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a child who volunteered to participate in the intervention study.
- Being a child with a recent diagnosis of CD.
- Being willing to follow a GFD.
Who cannot join
- A history of chronic diseases (e.g., cardiovascular diseases, diabetes, hyperthyroidism/hypothyroidism, hypercholesterolemia, hypertriglyceridemia, or hypertension) or other digestive pathologies requiring specific dietary advice.
- Lacking a desire to be part of the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dieta Sin Gluten Equilibrada y Segura: Estudio De Biomarcadores y De Los Factores Determinantes Para Alcanzar El Equilibrio Nutricional y La Ausencia de Síntomas
The only treatment for celiac disease (CD) consists of following a strict lifelong gluten-free diet, which may lead to potential dietary imbalances and associated diseases. Although individualized dietary counseling should be mandatory for people with celiac disease, they often do not receive this information, and there are few specific biomarkers that provide information about their progression and nutritional status.
Moreover, in the classic form of CD, gastrointestinal symptoms caused by gluten ingestion predominate. One might assume that removing this protein from the diet would lead to the complete remission of these symptoms; however, it has been shown that this is not always the case. Therefore, research into other possible dietary triggers of persistent symptoms is of great interest (including FODMAPs, ATIs, or histamine).
Read more
On the other hand, individuals within the celiac and gluten-sensitive (C-GS) community sometimes feel misunderstood by society, which makes greater education necessary both for this group and for their surroundings (the general population) to ensure their full social inclusion.
This project aims to improve the quality of life of people with C-GS by acting within the healthcare setting through dietary intervention and nutritional education; from a scientific perspective, by investigating possible causes of their symptoms and identifying biomarkers to help monitor their treatment and progression; and from a social perspective, by promoting knowledge about CD and the gluten-free diet among the general population. It also provides new technological tools for self-care and clinician-patient communication.
Read the detailed description
GENERAL AND SPECIFIC OBJECTIVES
The aim of this project is to improve the quality of life of people with celiac disease-gluten sensitivity (CD-GS) by studying factors that may determine the success of a gluten-free diet (GFD). To this end, the following general (G) and specific (E) objectives have been established:
G1. Improvement of software for nutritional assessment and safety of the gluten-free diet.
Since removing gluten from the diet is not an easy task and often leads to dietary imbalance and risk of unintentional consumption, the goal is to enhance the GlutenFreeDiet software by incorporating new features, a wider range of specific gluten-free foods, and a more appealing and intuitive graphic design. In addition, a tool will be developed to allow users to identify, measure, and provide data on the FODMAP, ATI, and histamine content of foods, facilitating progress in determining the relationship between these compounds and persistent symptoms in individuals with CD following a GFD.
Specific objectives under G1:
E1. Improvement and adaptation of the software with new functionalities.
E2. Quantification of FODMAPs, ATIs, and histamine content in both conventional foods and foods specifically produced for people with celiac disease, followed by updating the software database with experimental or literature-based data.
E3. Determination of FODMAP, ATI, and histamine intake among the pediatric and adolescent CD-GS population in the Basque Autonomous Community (CAPV).
G2. Promotion of a healthy nutritional status in people with CD-GS. Eliminating gluten from the diet also removes key foods that are important sources of fiber and micronutrients, potentially leading to imbalances that affect health and even compromise growth in children. To improve dietary habits and prevent deficiencies and dietary transgressions, it is necessary to analyze how individuals adapt to their new diet and support them throughout this process by identifying errors, symptoms, intake of suspected triggering compounds, and measuring quality-of-life parameters. This will enable personalized counseling and education. Furthermore, characterizing and monitoring new non-invasive biomarkers that may be useful in the clinical management of GFD and related conditions is of great interest.
Specific objectives under G2:
E4. Assessment and monitoring of nutritional status, dietary habits, GFD adherence, symptoms, and quality of life in the pediatric and adolescent CD-GS population.
E5. Study of novel blood biomarkers that may help monitor disease progression during GFD treatment.
E6. Analysis of the relationship between symptoms and dietary habits, including the role of FODMAPs, ATIs, histamine (E2), and blood parameters (E5) in symptom persistence.
E7. Personalized dietary intervention and nutrition education to optimize participants' nutritional status.
G3. Expanding knowledge about CD-GS and the gluten-free diet in this population and in society at large.
Since socialization and safety in unfamiliar environments affect quality of life, education is necessary not only for the celiac community but also for their surroundings and society as a whole. Awareness will foster inclusion, reduce anxiety about accidental exposure, and improve mood and quality of life.
E8. Design and implementation of scientific outreach activities on gluten and celiac disease aimed at children and their families.
METHODOLOGY AND WORK PLAN
The objectives will be addressed through a series of tasks organized into three stages.
STAGE 1: IMPROVEMENT OF THE "GLUTENFREEDIET" SOFTWARE
Task 1. Software improvement and expansion (E1). Development of a digital solution to support healthcare professionals and enhance self-care for CD-GS individuals. This includes expanding the gluten-free product database, adding nutrition education features, improving visual design, enabling inclusion of homemade recipes, and expanding vegetarian options.
Task 2. Quantification of potentially harmful molecules (E2). Database expansion with literature and experimental data on ATIs, histamine, and FODMAPs. Analytical quantification will include fructans (via spectrophotometry) and other FODMAPs (ion chromatography). Thirty gluten-free cereal-based products will be analyzed. Histamine and ATIs will be measured using ELISA and enzymatic activity assays.
Task 3. Determination of intake of these compounds in the pediatric CD-GS population of the Basque Country (E3).
Dietary intake will be assessed using 24-hour recalls, and consumption of these compounds will be calculated.
Milestones:
Improved GlutenFreeDiet software
Determination of food content in FODMAPs, ATIs, histamine
Quantification of intake of potentially harmful molecules
STAGE 2: ASSESSMENT AND MONITORING OF NUTRITIONAL STATUS AND DIETARY HABITS
Conducted with six pediatric gastroenterology units. Recently diagnosed patients (3-14 years) will be followed at diagnosis (VT0), 3 months (VT3), and 12 months (VT12).
Task 4 (E4): Nutritional, dietary, symptom, and quality-of-life assessments. Task 5 (E5): Blood and urine biomarker analysis (microRNAs, citrulline, platelet volume, antioxidant capacity, membrane lipidomics, GIPs in urine, etc.).
Task 6 (E6): Relationship between symptoms, dietary compounds, and biomarkers. Task 7 (E7): Personalized dietary intervention and education (sessions at month 1, 4, and 13).
Milestones:
- Improved nutritional status and habits 5. Definition of biomarkers 6. Role of FODMAPs, ATIs, histamine in symptoms
STAGE 3: INCREASING SOCIETAL AWARENESS
Task 8 (E8): Outreach workshops in schools and family settings, gluten detection activities, labeling education, sensory analysis of gluten-free foods, and balanced GFD design. Activities will also be disseminated through social media and the GLUTEN3S research group website.
Milestone 7: Increased societal knowledge of CD and the GFD through educational outreach.
- Being tested
- Dietary assesment for children with celiac disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary assesment for children with celiac diseaseOther
Also called Measurement of symptoms, quality of life and biomarkers
Children with recent diagnosis in celiac disease receive nutritional education and advice during the first yaer on a gluten free diet.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary habits measurement
The consumption of all foods of daily and weekly intake was measured after the intervention. the consumption of foods was measured as protions /day or portions/week.
Measured: 1 year
Gastrointestinal and Extra-intestinal sympthoms measurements
The quantity and the intensity of gastro intestinal symptoms were measured with Gastrointestinal Symptom Rating Scale (GSGR) questionnaire. The GSGR questionnaire assesses 15 gastrointestinal and diet-related symptoms at different levels of intensity. When symptom burden is evaluated as the number of reported symptoms, the total score ranges from 0 to 15, with values close to 0 indicate absence of symptoms and values close to 15 all assessed symptoms. When symptom severity is considered, the total score ranges from 0 to 90, with values close to 0 indicating few symptoms at low intensity and values close to 90 many symptoms at high intensity.
Extra intestinal symptoms presence was measured with a questionnaire that was adapted from a questionnaire used to measure 12 of these sympthoms in Non Gluten Celiac Sensitivity, 0 indicates no sympthoms and 12 all of them.
Measured: 1 year
Quality of life measurement
A total score of quality of life as well as the score in three subscales (having celiac disease, Diet and communication were analyzed. The scales went from 1 (very poor queality of life) to 5 (very good quality of life) points.
Measured: 1 year
Biomarkers analysis
FABP and citrulline were measured in serum through ELISA method.
Measured: 1 year
Serum protein and cytokine expression measurement
92 serum proteins were analyzed using Proximity Extension Assay (PEA) technology, implemented through the Olink® Target 96 Inflammation panel.
Measured: 1 year
miRNA analysis
A library of 644 circulating miRNAs were measured. miRNA sequencing libraries were prepared using the Lexogen Small RNA-Seq Library Prep Kit.
Measured: 1 year
Gluten Inmunogenic Peptides (GIP) quantification
GIP presence in urine and stool was measured by ELISA techniques.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 May 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CHILDREN RECENTLY DIAGNOSED OF CELIAC DISEASE
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Collaborators
- Osakidetza, Asociación de Celiacos y Sensibles al Gluten de Madrid, Asociación de Celiacos de Euskadi
- Responsible party
- Principal investigator, Arrate Lasa, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436884
- Sponsor's protocol ID
- PID2021-125695OA-I00
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided yet
Publications
Perez-Junkera G, Lasa A, Delgado-Sanzonetti L, Lekuona Serrano A, Vazquez-Polo M, Churruca I, Navarro V, Larretxi I. Celiac disease in children with focus on symptoms and quality of life. Sci Rep. 2025 Oct 15;15(1):36079. doi: 10.1038/s41598-025-19973-w.
PubMed 41094115Vazquez-Polo M, Churruca I, Perez-Junkera G, Larretxi I, Lasa A, Esparta J, Cantero-Ruiz de Eguino L, Navarro V. Study Protocol for a Controlled Trial of Nutrition Education Intervention about Celiac Disease in Primary School: ZELIAKIDE Project. Nutrients. 2024 Jan 23;16(3):338. doi: 10.3390/nu16030338.
PubMed 38337623Perez-Junkera G, Simon E, Calvo AE, Garcia Casales Z, Oliver Goicolea P, Serrano-Vela JI, Larretxi I, Lasa A. Importance of an Ongoing Nutritional Counselling Intervention on Eating Habits of Newly Diagnosed Children with Celiac Disease. Nutrients. 2024 Jul 25;16(15):2418. doi: 10.3390/nu16152418.
PubMed 39125299Vazquez-Polo M, Navarro V, Perez-Junkera G, Lasa A, Larretxi I, Miranda J, Esparta J, Churruca I. Assessment of a training course for cookery students regarding celiac disease and gluten-free diet. Heliyon. 2024 Oct 12;10(20):e39060. doi: 10.1016/j.heliyon.2024.e39060. eCollection 2024 Oct 30.
PubMed 39492888Vazquez-Polo M, Navarro V, Larretxi I, Perez-Junkera G, Lasa A, Matias S, Simon E, Churruca I. Uncovering the Concerns and Needs of Individuals with Celiac Disease: A Cross-Sectional Study. Nutrients. 2023 Aug 22;15(17):3681. doi: 10.3390/nu15173681.
PubMed 37686713Matias S, Perez-Junkera G, Martinez O, Miranda J, Larretxi I, Pena L, Bustamante MA, Churruca I, Simon E. FODMAP Content Like-by-like Comparison in Spanish Gluten-free and Gluten-containing Cereal-based Products. Plant Foods Hum Nutr. 2024 Jun;79(2):545-550. doi: 10.1007/s11130-024-01177-8. Epub 2024 Apr 20.
PubMed 38642193Perez-Junkera G, Ruiz de Azua L, Vazquez-Polo M, Lasa A, Fernandez Gil MP, Txurruka I, Navarro V, Larretxi I. Global Approach to Follow-Up of Celiac Disease. Foods. 2024 May 8;13(10):1449. doi: 10.3390/foods13101449.
PubMed 38790748
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dieta Sin Gluten Equilibrada y Segura: Estudio De Biomarcadores y De Los Factores Determinantes Para Alcanzar El Equilibrio Nutricional y La Ausencia de Síntomas
- ClinicalTrials.gov ID
- NCT07436884
- Acronym / sponsor ID
- PID2021-125695OA-I00
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Collaborators
- Osakidetza, Asociación de Celiacos y Sensibles al Gluten de Madrid, Asociación de Celiacos de Euskadi
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 27 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 only treatment for celiac disease (CD) consists of following a strict lifelong gluten-free diet, which may lead to potential dietary imbalances and associated diseases. Although individualized dietary counseling should be mandatory for people with celiac disease, they often do not receive this information, and there are few specific biomarkers that provide information about their progression and nutritional status.
Moreover, in the classic form of CD, gastrointestinal symptoms caused by gluten ingestion predominate. One might assume that removing this protein from the diet would lead to the complete remission of these symptoms; however, it has been shown that this is not always the case. Therefore, research into other possible dietary triggers of persistent symptoms is of great interest (including FODMAPs, ATIs, or histamine).
On the other hand, individuals within the celiac and gluten-sensitive (C-GS) community sometimes feel misunderstood by society, which makes greater education necessary both for this group and for their surroundings (the general population) to ensure their full social inclusion.
This project aims to improve the quality of life of people with C-GS by acting within the healthcare setting through dietary intervention and nutritional education; from a scientific perspective, by investigating possible causes of their symptoms and identifying biomarkers to help monitor their treatment and progression; and from a social perspective, by promoting knowledge about CD and the gluten-free diet among the general population. It also provides new technological tools for self-care and clinician-patient communication.
Detailed description
GENERAL AND SPECIFIC OBJECTIVES
The aim of this project is to improve the quality of life of people with celiac disease-gluten sensitivity (CD-GS) by studying factors that may determine the success of a gluten-free diet (GFD). To this end, the following general (G) and specific (E) objectives have been established:
G1. Improvement of software for nutritional assessment and safety of the gluten-free diet.
Since removing gluten from the diet is not an easy task and often leads to dietary imbalance and risk of unintentional consumption, the goal is to enhance the GlutenFreeDiet software by incorporating new features, a wider range of specific gluten-free foods, and a more appealing and intuitive graphic design. In addition, a tool will be developed to allow users to identify, measure, and provide data on the FODMAP, ATI, and histamine content of foods, facilitating progress in determining the relationship between these compounds and persistent symptoms in individuals with CD following a GFD.
Specific objectives under G1:
E1. Improvement and adaptation of the software with new functionalities.
E2. Quantification of FODMAPs, ATIs, and histamine content in both conventional foods and foods specifically produced for people with celiac disease, followed by updating the software database with experimental or literature-based data.
E3. Determination of FODMAP, ATI, and histamine intake among the pediatric and adolescent CD-GS population in the Basque Autonomous Community (CAPV).
G2. Promotion of a healthy nutritional status in people with CD-GS. Eliminating gluten from the diet also removes key foods that are important sources of fiber and micronutrients, potentially leading to imbalances that affect health and even compromise growth in children. To improve dietary habits and prevent deficiencies and dietary transgressions, it is necessary to analyze how individuals adapt to their new diet and support them throughout this process by identifying errors, symptoms, intake of suspected triggering compounds, and measuring quality-of-life parameters. This will enable personalized counseling and education. Furthermore, characterizing and monitoring new non-invasive biomarkers that may be useful in the clinical management of GFD and related conditions is of great interest.
Specific objectives under G2:
E4. Assessment and monitoring of nutritional status, dietary habits, GFD adherence, symptoms, and quality of life in the pediatric and adolescent CD-GS population.
E5. Study of novel blood biomarkers that may help monitor disease progression during GFD treatment.
E6. Analysis of the relationship between symptoms and dietary habits, including the role of FODMAPs, ATIs, histamine (E2), and blood parameters (E5) in symptom persistence.
E7. Personalized dietary intervention and nutrition education to optimize participants' nutritional status.
G3. Expanding knowledge about CD-GS and the gluten-free diet in this population and in society at large.
Since socialization and safety in unfamiliar environments affect quality of life, education is necessary not only for the celiac community but also for their surroundings and society as a whole. Awareness will foster inclusion, reduce anxiety about accidental exposure, and improve mood and quality of life.
E8. Design and implementation of scientific outreach activities on gluten and celiac disease aimed at children and their families.
METHODOLOGY AND WORK PLAN
The objectives will be addressed through a series of tasks organized into three stages.
STAGE 1: IMPROVEMENT OF THE "GLUTENFREEDIET" SOFTWARE
Task 1. Software improvement and expansion (E1). Development of a digital solution to support healthcare professionals and enhance self-care for CD-GS individuals. This includes expanding the gluten-free product database, adding nutrition education features, improving visual design, enabling inclusion of homemade recipes, and expanding vegetarian options.
Task 2. Quantification of potentially harmful molecules (E2). Database expansion with literature and experimental data on ATIs, histamine, and FODMAPs. Analytical quantification will include fructans (via spectrophotometry) and other FODMAPs (ion chromatography). Thirty gluten-free cereal-based products will be analyzed. Histamine and ATIs will be measured using ELISA and enzymatic activity assays.
Task 3. Determination of intake of these compounds in the pediatric CD-GS population of the Basque Country (E3).
Dietary intake will be assessed using 24-hour recalls, and consumption of these compounds will be calculated.
Milestones:
Improved GlutenFreeDiet software
Determination of food content in FODMAPs, ATIs, histamine
Quantification of intake of potentially harmful molecules
STAGE 2: ASSESSMENT AND MONITORING OF NUTRITIONAL STATUS AND DIETARY HABITS
Conducted with six pediatric gastroenterology units. Recently diagnosed patients (3-14 years) will be followed at diagnosis (VT0), 3 months (VT3), and 12 months (VT12).
Task 4 (E4): Nutritional, dietary, symptom, and quality-of-life assessments. Task 5 (E5): Blood and urine biomarker analysis (microRNAs, citrulline, platelet volume, antioxidant capacity, membrane lipidomics, GIPs in urine, etc.).
Task 6 (E6): Relationship between symptoms, dietary compounds, and biomarkers. Task 7 (E7): Personalized dietary intervention and education (sessions at month 1, 4, and 13).
Milestones:
- Improved nutritional status and habits 5. Definition of biomarkers 6. Role of FODMAPs, ATIs, histamine in symptoms
STAGE 3: INCREASING SOCIETAL AWARENESS
Task 8 (E8): Outreach workshops in schools and family settings, gluten detection activities, labeling education, sensory analysis of gluten-free foods, and balanced GFD design. Activities will also be disseminated through social media and the GLUTEN3S research group website.
Milestone 7: Increased societal knowledge of CD and the GFD through educational outreach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Model description
- CHILDREN RECENTLY DIAGNOSED OF CELIAC DISEASE
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being a child who volunteered to participate in the intervention study.
- Being a child with a recent diagnosis of CD.
- Being willing to follow a GFD.
Key exclusion criteria (2 listed)
- A history of chronic diseases (e.g., cardiovascular diseases, diabetes, hyperthyroidism/hypothyroidism, hypercholesterolemia, hypertriglyceridemia, or hypertension) or other digestive pathologies requiring specific dietary advice.
- Lacking a desire to be part of the intervention.
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 |
|---|---|---|
| Dietary assesment for children with celiac diseaseAlso: Measurement of symptoms, quality of life and biomarkersChildren with recent diagnosis in celiac disease receive nutritional education and advice during the first yaer on a gluten free diet. | Other | – |
Primary outcome
Dietary habits measurement
Time frame: 1 year
The consumption of all foods of daily and weekly intake was measured after the intervention. the consumption of foods was measured as protions /day or portions/week.
Gastrointestinal and Extra-intestinal sympthoms measurements
Time frame: 1 year
The quantity and the intensity of gastro intestinal symptoms were measured with Gastrointestinal Symptom Rating Scale (GSGR) questionnaire. The GSGR questionnaire assesses 15 gastrointestinal and diet-related symptoms at different levels of intensity. When symptom burden is evaluated as the number of reported symptoms, the total score ranges from 0 to 15, with values close to 0 indicate absence of symptoms and values close to 15 all assessed symptoms. When symptom severity is considered, the total score ranges from 0 to 90, with values close to 0 indicating few symptoms at low intensity and values close to 90 many symptoms at high intensity. Extra intestinal symptoms presence was measured with a questionnaire that was adapted from a questionnaire used to measure 12 of these sympthoms in Non Gluten Celiac Sensitivity, 0 indicates no sympthoms and 12 all of them.
Quality of life measurement
Time frame: 1 year
A total score of quality of life as well as the score in three subscales (having celiac disease, Diet and communication were analyzed. The scales went from 1 (very poor queality of life) to 5 (very good quality of life) points.
Biomarkers analysis
Time frame: 1 year
FABP and citrulline were measured in serum through ELISA method.
Serum protein and cytokine expression measurement
Time frame: 1 year
92 serum proteins were analyzed using Proximity Extension Assay (PEA) technology, implemented through the Olink® Target 96 Inflammation panel.
miRNA analysis
Time frame: 1 year
A library of 644 circulating miRNAs were measured. miRNA sequencing libraries were prepared using the Lexogen Small RNA-Seq Library Prep Kit.
Gluten Inmunogenic Peptides (GIP) quantification
Time frame: 1 year
GIP presence in urine and stool was measured by ELISA techniques.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 41094115Perez-Junkera G, Lasa A, Delgado-Sanzonetti L, Lekuona Serrano A, Vazquez-Polo M, Churruca I, Navarro V, Larretxi I. Celiac disease in children with focus on symptoms and quality of life. Sci Rep. 2025 Oct 15;15(1):36079. doi: 10.1038/s41598-025-19973-w.
- Results publication: PubMed 38337623Vazquez-Polo M, Churruca I, Perez-Junkera G, Larretxi I, Lasa A, Esparta J, Cantero-Ruiz de Eguino L, Navarro V. Study Protocol for a Controlled Trial of Nutrition Education Intervention about Celiac Disease in Primary School: ZELIAKIDE Project. Nutrients. 2024 Jan 23;16(3):338. doi: 10.3390/nu16030338.
- Results publication: PubMed 39125299Perez-Junkera G, Simon E, Calvo AE, Garcia Casales Z, Oliver Goicolea P, Serrano-Vela JI, Larretxi I, Lasa A. Importance of an Ongoing Nutritional Counselling Intervention on Eating Habits of Newly Diagnosed Children with Celiac Disease. Nutrients. 2024 Jul 25;16(15):2418. doi: 10.3390/nu16152418.
- Results publication: PubMed 39492888Vazquez-Polo M, Navarro V, Perez-Junkera G, Lasa A, Larretxi I, Miranda J, Esparta J, Churruca I. Assessment of a training course for cookery students regarding celiac disease and gluten-free diet. Heliyon. 2024 Oct 12;10(20):e39060. doi: 10.1016/j.heliyon.2024.e39060. eCollection 2024 Oct 30.
- Results publication: PubMed 37686713Vazquez-Polo M, Navarro V, Larretxi I, Perez-Junkera G, Lasa A, Matias S, Simon E, Churruca I. Uncovering the Concerns and Needs of Individuals with Celiac Disease: A Cross-Sectional Study. Nutrients. 2023 Aug 22;15(17):3681. doi: 10.3390/nu15173681.
- Results publication: PubMed 38642193Matias S, Perez-Junkera G, Martinez O, Miranda J, Larretxi I, Pena L, Bustamante MA, Churruca I, Simon E. FODMAP Content Like-by-like Comparison in Spanish Gluten-free and Gluten-containing Cereal-based Products. Plant Foods Hum Nutr. 2024 Jun;79(2):545-550. doi: 10.1007/s11130-024-01177-8. Epub 2024 Apr 20.
- Results publication: PubMed 38790748Perez-Junkera G, Ruiz de Azua L, Vazquez-Polo M, Lasa A, Fernandez Gil MP, Txurruka I, Navarro V, Larretxi I. Global Approach to Follow-Up of Celiac Disease. Foods. 2024 May 8;13(10):1449. doi: 10.3390/foods13101449.
- Individual participant dataSharing planned: Undecided. We have not decided yet
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary assesment for children with celiac disease in people with Celiac Disease in Children and Nutrition, Healthy, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Mar 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dietary habits measurement (time frame: 1 year). The study lists 7 primary outcomes in all. 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 NCT07436884, which also lists 7 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 4 Mar 2026.