Safe and Secure Gluten Free Diet

NCT07436884 | Completed DMC

• 1 other identifier: PID2021-125695OA-I00
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  1 year

• Biomarkers analysis

  FABP and citrulline were measured in serum through ELISA method.

  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.

  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.

  1 year

• Gluten Inmunogenic Peptides (GIP) quantification

  GIP presence in urine and stool was measured by ELISA techniques.

  1 year

Interventions

Dietary assesment for children with celiac disease OTHER

Children with recent diagnosis in celiac disease receive nutritional education and advice during the first yaer on a gluten free diet.

Also known as: Measurement of symptoms, quality of life and biomarkers

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• Osakidetza: collaborator
• Asociación de Celiacos de Euskadi: collaborator
• Asociación de Celiacos y Sensibles al Gluten de Madrid: collaborator

Study Sites (1)

Arrate Lasa

Vitoria-Gasteiz, Alava, 01006, Spain

Location

Related Publications (7)

• 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.

  PMID: 41094115 RESULT

• Vazquez-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.

  PMID: 38337623 RESULT

• Perez-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.

  PMID: 39125299 RESULT

• Vazquez-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.

  PMID: 39492888 RESULT

• Vazquez-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.

  PMID: 37686713 RESULT

• Matias 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.

  PMID: 38642193 RESULT

• Perez-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.

  PMID: 38790748 RESULT

MeSH Terms

Interventions

Quality of Life; Biomarkers

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants receive nutritional assesment from care providers (dietitians) and investigators analyze data collected from participants and biomarkers in collected serum, urine and stool.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: CHILDREN RECENTLY DIAGNOSED OF CELIAC DISEASE

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

ES (1)