NCT07436884

Safe and Secure Gluten Free Diet

Dieta Sin Gluten Equilibrada y Segura: Estudio De Biomarcadores y De Los Factores Determinantes Para Alcanzar El Equilibrio Nutricional y La Ausencia de Síntomas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: University of the Basque Country (UPV/EHU) · Academic / Other
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Accepted

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 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: 4\. 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.

Conditions

• Celiac Disease in Children
• Nutrition, Healthy
• Quality of Life

Interventions

Type	Name	Description
OTHER	Dietary assesment for children with celiac disease	Children with recent diagnosis in celiac disease receive nutritional education and advice during the first yaer on a gluten free diet.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-07-31
• Completion: 2025-07-31
• First posted: 2026-02-27
• Last updated: 2026-03-04

Locations

1 site across 1 country: Spain