Celiac DiseaseNCT05094232
Coeliac Disease in Spain: Determination of Disease Prevalence and Risk Factors
An observational study of Celiac Disease, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- How many people
- 4,826 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants are selected from ambulatory minor surgery departments of the pediatric and general tertiary referral hospitals in Spain. Regarding age and sex, inclusion is done reproducing the reference population of each participating Spanish regions (according to data from the Spanish Statistics Institute).
Who may be able to join
- Age 1 to ≥80 years old
Who cannot join
- Heart failure or unstable ischemic cardiopathy
- Chronic obstructive pulmonary disease or respiratory insufficiency
- Coagulopathy
- Diabetes mellitus type II with vascular complications
- Hepatic cirrhosis
- Kidney failure (Creatinine >1.5 mg/dL o glomerular filtration <30 ml /min)
Show all 9Show fewer
- Active neoplasm
- Pregnancy
- Gluten-free diet without CD diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiologic Evolution of Coeliac Disease in Spain and Risk Factors Influencing Disease Prevalence
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.
- Conditions
- Celiac Disease
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue transglutaminase IgA antibodies (tTGA) detection in blood serum (serological CD marker)
Measured: at the time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,826 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094232
- Sponsor's protocol ID
- EHD20PI01
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singh P, Arora A, Strand TA, Leffler DA, Catassi C, Green PH, Kelly CP, Ahuja V, Makharia GK. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037. Epub 2018 Mar 16.
PubMed 29551598Pratesi R, Gandolfi L, Garcia SG, Modelli IC, Lopes de Almeida P, Bocca AL, Catassi C. Prevalence of coeliac disease: unexplained age-related variation in the same population. Scand J Gastroenterol. 2003 Jul;38(7):747-50. doi: 10.1080/00365520310003255.
PubMed 12889561Beatriz Arau; Meritxell Mariné; Carme Farré; Beatriz Dietl; Roger García-Puig; Laura Martí-Cosconera; Anna Carrasco; Eva Tristán; Teresa Marqués; Víctor Vila; Clàudia Fortuny, Maria Esteve. Història natural de la malaltia celíaca (MC): seguiment longitudinal a llarg termini amb dieta lliure de nens asimptomàtics detectats per cribratge poblacional. Resultats preliminars. XXVII Congrés de la Societat Catalana de Digestologia. Girona: 25-27 de gener de 2018. (Annals de Medicina 2018; Suplements Vol. 101 supl. 1)
Myleus A, Ivarsson A, Webb C, Danielsson L, Hernell O, Hogberg L, Karlsson E, Lagerqvist C, Norstrom F, Rosen A, Sandstrom O, Stenhammar L, Stenlund H, Wall S, Carlsson A. Celiac disease revealed in 3% of Swedish 12-year-olds born during an epidemic. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):170-6. doi: 10.1097/MPG.0b013e31818c52cc.
PubMed 19516192Szajewska H, Shamir R, Chmielewska A, Piescik-Lech M, Auricchio R, Ivarsson A, Kolacek S, Koletzko S, Korponay-Szabo I, Mearin ML, Ribes-Koninckx C, Troncone R; PREVENTCD Study Group. Systematic review with meta-analysis: early infant feeding and coeliac disease--update 2015. Aliment Pharmacol Ther. 2015 Jun;41(11):1038-54. doi: 10.1111/apt.13163. Epub 2015 Mar 26.
PubMed 25819114Namatovu F, Lindkvist M, Olsson C, Ivarsson A, Sandstrom O. Season and region of birth as risk factors for coeliac disease a key to the aetiology? Arch Dis Child. 2016 Dec;101(12):1114-1118. doi: 10.1136/archdischild-2015-310122. Epub 2016 Aug 15.
PubMed 27528621Zanoni G, Navone R, Lunardi C, Tridente G, Bason C, Sivori S, Beri R, Dolcino M, Valletta E, Corrocher R, Puccetti A. In celiac disease, a subset of autoantibodies against transglutaminase binds toll-like receptor 4 and induces activation of monocytes. PLoS Med. 2006 Sep;3(9):e358. doi: 10.1371/journal.pmed.0030358.
PubMed 16984219Kahrs CR, Chuda K, Tapia G, Stene LC, Marild K, Rasmussen T, Ronningen KS, Lundin KEA, Kramna L, Cinek O, Stordal K. Enterovirus as trigger of coeliac disease: nested case-control study within prospective birth cohort. BMJ. 2019 Feb 13;364:l231. doi: 10.1136/bmj.l231.
PubMed 30760441Kemppainen KM, Lynch KF, Liu E, Lonnrot M, Simell V, Briese T, Koletzko S, Hagopian W, Rewers M, She JX, Simell O, Toppari J, Ziegler AG, Akolkar B, Krischer JP, Lernmark A, Hyoty H, Triplett EW, Agardh D; TEDDY Study Group. Factors That Increase Risk of Celiac Disease Autoimmunity After a Gastrointestinal Infection in Early Life. Clin Gastroenterol Hepatol. 2017 May;15(5):694-702.e5. doi: 10.1016/j.cgh.2016.10.033. Epub 2016 Nov 10.
PubMed 27840181Lindfors K, Lin J, Lee HS, Hyoty H, Nykter M, Kurppa K, Liu E, Koletzko S, Rewers M, Hagopian W, Toppari J, Ziegler AG, Akolkar B, Krischer JP, Petrosino JF, Lloyd RE, Agardh D; TEDDY Study Group. Metagenomics of the faecal virome indicate a cumulative effect of enterovirus and gluten amount on the risk of coeliac disease autoimmunity in genetically at risk children: the TEDDY study. Gut. 2020 Aug;69(8):1416-1422. doi: 10.1136/gutjnl-2019-319809. Epub 2019 Nov 19.
PubMed 31744911Namatovu F, Olsson C, Lindkvist M, Myleus A, Hogberg U, Ivarsson A, Sandstrom O. Maternal and perinatal conditions and the risk of developing celiac disease during childhood. BMC Pediatr. 2016 Jun 8;16:77. doi: 10.1186/s12887-016-0613-y.
PubMed 27267234Kemppainen KM, Vehik K, Lynch KF, Larsson HE, Canepa RJ, Simell V, Koletzko S, Liu E, Simell OG, Toppari J, Ziegler AG, Rewers MJ, Lernmark A, Hagopian WA, She JX, Akolkar B, Schatz DA, Atkinson MA, Blaser MJ, Krischer JP, Hyoty H, Agardh D, Triplett EW; Environmental Determinants of Diabetes in the Young (TEDDY) Study Group. Association Between Early-Life Antibiotic Use and the Risk of Islet or Celiac Disease Autoimmunity. JAMA Pediatr. 2017 Dec 1;171(12):1217-1225. doi: 10.1001/jamapediatrics.2017.2905.
PubMed 29052687Dydensborg Sander S, Nybo Andersen AM, Murray JA, Karlstad O, Husby S, Stordal K. Association Between Antibiotics in the First Year of Life and Celiac Disease. Gastroenterology. 2019 Jun;156(8):2217-2229. doi: 10.1053/j.gastro.2019.02.039. Epub 2019 Mar 2.
PubMed 30836095Riestra S, Fernandez E, Rodrigo L, Garcia S, Ocio G. Prevalence of Coeliac disease in the general population of northern Spain. Strategies of serologic screening. Scand J Gastroenterol. 2000 Apr;35(4):398-402. doi: 10.1080/003655200750023967.
PubMed 10831263Castano L, Blarduni E, Ortiz L, Nunez J, Bilbao JR, Rica I, Martul P, Vitoria JC. Prospective population screening for celiac disease: high prevalence in the first 3 years of life. J Pediatr Gastroenterol Nutr. 2004 Jul;39(1):80-4. doi: 10.1097/00005176-200407000-00016.
PubMed 15187786
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Evolution of Coeliac Disease in Spain and Risk Factors Influencing Disease Prevalence
- ClinicalTrials.gov ID
- NCT05094232
- Acronym / sponsor ID
- EHD20PI01
- Conditions
- Celiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,826 participants (actual)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are selected from ambulatory minor surgery departments of the pediatric and general tertiary referral hospitals in Spain. Regarding age and sex, inclusion is done reproducing the reference population of each participating Spanish regions (according to data from the Spanish Statistics Institute).
Key inclusion criteria (1 listed)
- Age 1 to ≥80 years old
Key exclusion criteria (9 listed)
- Heart failure or unstable ischemic cardiopathy
- Chronic obstructive pulmonary disease or respiratory insufficiency
- Coagulopathy
- Diabetes mellitus type II with vascular complications
- Hepatic cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tissue transglutaminase IgA antibodies (tTGA) detection in blood serum (serological CD marker)
Time frame: at the time of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 29551598Singh P, Arora A, Strand TA, Leffler DA, Catassi C, Green PH, Kelly CP, Ahuja V, Makharia GK. Global Prevalence of Celiac Disease: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2018 Jun;16(6):823-836.e2. doi: 10.1016/j.cgh.2017.06.037. Epub 2018 Mar 16.
- Background: PubMed 12889561Pratesi R, Gandolfi L, Garcia SG, Modelli IC, Lopes de Almeida P, Bocca AL, Catassi C. Prevalence of coeliac disease: unexplained age-related variation in the same population. Scand J Gastroenterol. 2003 Jul;38(7):747-50. doi: 10.1080/00365520310003255.
- BackgroundBeatriz Arau; Meritxell Mariné; Carme Farré; Beatriz Dietl; Roger García-Puig; Laura Martí-Cosconera; Anna Carrasco; Eva Tristán; Teresa Marqués; Víctor Vila; Clàudia Fortuny, Maria Esteve. Història natural de la malaltia celíaca (MC): seguiment longitudinal a llarg termini amb dieta lliure de nens asimptomàtics detectats per cribratge poblacional. Resultats preliminars. XXVII Congrés de la Societat Catalana de Digestologia. Girona: 25-27 de gener de 2018. (Annals de Medicina 2018; Suplements Vol. 101 supl. 1)
- Background: PubMed 19516192Myleus A, Ivarsson A, Webb C, Danielsson L, Hernell O, Hogberg L, Karlsson E, Lagerqvist C, Norstrom F, Rosen A, Sandstrom O, Stenhammar L, Stenlund H, Wall S, Carlsson A. Celiac disease revealed in 3% of Swedish 12-year-olds born during an epidemic. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):170-6. doi: 10.1097/MPG.0b013e31818c52cc.
- Background: PubMed 25819114Szajewska H, Shamir R, Chmielewska A, Piescik-Lech M, Auricchio R, Ivarsson A, Kolacek S, Koletzko S, Korponay-Szabo I, Mearin ML, Ribes-Koninckx C, Troncone R; PREVENTCD Study Group. Systematic review with meta-analysis: early infant feeding and coeliac disease--update 2015. Aliment Pharmacol Ther. 2015 Jun;41(11):1038-54. doi: 10.1111/apt.13163. Epub 2015 Mar 26.
- Background: PubMed 27528621Namatovu F, Lindkvist M, Olsson C, Ivarsson A, Sandstrom O. Season and region of birth as risk factors for coeliac disease a key to the aetiology? Arch Dis Child. 2016 Dec;101(12):1114-1118. doi: 10.1136/archdischild-2015-310122. Epub 2016 Aug 15.
- Background: PubMed 16984219Zanoni G, Navone R, Lunardi C, Tridente G, Bason C, Sivori S, Beri R, Dolcino M, Valletta E, Corrocher R, Puccetti A. In celiac disease, a subset of autoantibodies against transglutaminase binds toll-like receptor 4 and induces activation of monocytes. PLoS Med. 2006 Sep;3(9):e358. doi: 10.1371/journal.pmed.0030358.
- Background: PubMed 30760441Kahrs CR, Chuda K, Tapia G, Stene LC, Marild K, Rasmussen T, Ronningen KS, Lundin KEA, Kramna L, Cinek O, Stordal K. Enterovirus as trigger of coeliac disease: nested case-control study within prospective birth cohort. BMJ. 2019 Feb 13;364:l231. doi: 10.1136/bmj.l231.
- Background: PubMed 27840181Kemppainen KM, Lynch KF, Liu E, Lonnrot M, Simell V, Briese T, Koletzko S, Hagopian W, Rewers M, She JX, Simell O, Toppari J, Ziegler AG, Akolkar B, Krischer JP, Lernmark A, Hyoty H, Triplett EW, Agardh D; TEDDY Study Group. Factors That Increase Risk of Celiac Disease Autoimmunity After a Gastrointestinal Infection in Early Life. Clin Gastroenterol Hepatol. 2017 May;15(5):694-702.e5. doi: 10.1016/j.cgh.2016.10.033. Epub 2016 Nov 10.
- Background: PubMed 31744911Lindfors K, Lin J, Lee HS, Hyoty H, Nykter M, Kurppa K, Liu E, Koletzko S, Rewers M, Hagopian W, Toppari J, Ziegler AG, Akolkar B, Krischer JP, Petrosino JF, Lloyd RE, Agardh D; TEDDY Study Group. Metagenomics of the faecal virome indicate a cumulative effect of enterovirus and gluten amount on the risk of coeliac disease autoimmunity in genetically at risk children: the TEDDY study. Gut. 2020 Aug;69(8):1416-1422. doi: 10.1136/gutjnl-2019-319809. Epub 2019 Nov 19.
- Background: PubMed 27267234Namatovu F, Olsson C, Lindkvist M, Myleus A, Hogberg U, Ivarsson A, Sandstrom O. Maternal and perinatal conditions and the risk of developing celiac disease during childhood. BMC Pediatr. 2016 Jun 8;16:77. doi: 10.1186/s12887-016-0613-y.
- Background: PubMed 29052687Kemppainen KM, Vehik K, Lynch KF, Larsson HE, Canepa RJ, Simell V, Koletzko S, Liu E, Simell OG, Toppari J, Ziegler AG, Rewers MJ, Lernmark A, Hagopian WA, She JX, Akolkar B, Schatz DA, Atkinson MA, Blaser MJ, Krischer JP, Hyoty H, Agardh D, Triplett EW; Environmental Determinants of Diabetes in the Young (TEDDY) Study Group. Association Between Early-Life Antibiotic Use and the Risk of Islet or Celiac Disease Autoimmunity. JAMA Pediatr. 2017 Dec 1;171(12):1217-1225. doi: 10.1001/jamapediatrics.2017.2905.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue transglutaminase IgA antibodies (tTGA) detection in blood serum (serological CD marker) (time frame: at the time of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05094232, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.