Last reviewed · How we verify
NCT05094232
Coeliac Disease in Spain: Determination of Disease Prevalence and Risk Factors
trial in Celiac Disease in 5,255 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Hospital Mutua de Terrassa |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 5,255 |
| Start date | 1 November 2020 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across Spain |
Conditions studied
- Celiac Disease — all drugs for Celiac Disease →
Sponsor
Hospital Mutua de Terrassa
Who can join
1 and older, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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) - Immunoglobulin A (IgA) antibodies detection in blood serum) with histological confirmation (small-intestinal biopsy) is used to detect CD cases and determine disease prevalence.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05094232
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Celiac Disease
Currently open trials in the same condition.
- NCT07239336 — Study of DONQ52 in Active Celiac Disease · Phase 2 · recruiting
- NCT07585669 — Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease · NA · recruiting
- NCT07063823 — A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease · Phase 1 · recruiting
- NCT06982963 — Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease · Phase 2 · recruiting
- NCT07177287 — The Effect of a Navigator Nurse- Supported Mobile Application Developed Based on the IMB Model on the Quality of Life of · NA · recruiting
Other Hospital Mutua de Terrassa trials
Trials by the same sponsor.
- NCT07070596 — Study of the NATURal History, Epidemiological, Clinical, Diagnostic and Therapeutic Aspects of CELiac Disease and Non-ce · recruiting
- NCT06404931 — Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment · Phase 2 · recruiting
- NCT05919433 — Detection Program for Patients With Primary Biliary Cholangitis Lost in the System · recruiting
- NCT06036680 — Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease · unknown
- NCT05708820 — Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05094232 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Mutua de Terrassa
- Last refreshed: 11 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05094232.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing