Safe and Secure Gluten Free Diet

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.

NCT Number	NCT07436884
Lead Sponsor	University of the Basque Country (UPV/EHU) Collaborators: Osakidetza, Asociación de Celiacos y Sensibles al Gluten de Madrid, Asociación de Celiacos de Euskadi
Conditions	Celiac Disease in Children, Nutrition, Healthy, Quality of Life
Enrollment	71 participants
Start Date	2022-05-01
Primary Completion	2023-07-31 (estimated)
Study Completion	2025-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-04