Previous studies have showed that Coeliac Disease (CD) prevalence is significantly higher in children compared with adults. The largest epidemiologic study carried out in Spain to date (n=4230) reported a higher CD prevalence in children (1:71) than in adults (1:357) during 2004-2007. To study whether this difference was due to environmental factors influencing infancy or the development of gluten tolerance with age, a natural history study in pediatric age was initiated in 2013. Unexpectedly, the prevalence in children of 1-2 years of age was lower (1:135) than the previously reported in 2004-2007 for that age group (1:25). During follow-up, 1/3 of the asymptomatic cases showed reversion of the intestinal lesion and/or negativization of CD serological markers while continuing on a gluten-containing diet. Therefore, the development of gluten tolerance seems to have a major effect in age-related differences in CD prevalence. However, gluten tolerance phenomenon does not explain the differences found between the 2013-2019 and the 2004-2007 cohorts, suggesting that environmental factors may contribute as well. Apart from genetic factors, several environmental factors are believed to influence disease appearance, such as the time that gluten is introduced to the diet, viral infections, type of birth, antibiotic treatments, etc. Therefore, development of tolerance and environmental factors seem to equally play an important role in age-related differences in CD prevalence. However, more data is needed in order to know how environmental factors influence disease prevalence in Spain. Also, the previous studies carried in Spain were performed in specific geographical areas: Asturias, Basque Country and Catalonia using slightly different methodology and focused on different age groups, thus making results comparison and global extrapolation challenging. In this study, the investigators aim to determine global CD prevalence in Spain during 2020-2021 and: 1) compare it with the results obtained in previous studies; and 2) identify whether there are any differences associated with age, environmental factors and/or geographical area. For this purpose: a) participants are recruited based on the reference population regarding age and gender; b) recruitment is done in 5 different geographical areas in Spain: Andalusia, Asturias, Basque Country, Catalonia and Madrid; c) relevant clinical, social and environmental data is collected and d) serologic screening (anti-tissue transglutaminase (tTG)
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 1 Year and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05094232 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Hospital Mutua de Terrassa |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Spain |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Celiac Disease |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Opt-in to stay up-to-date on the latest news.
Yes, I want to advance research No, I'd prefer not to