Eosinophilic EsophagitisPRESONCT06443346
Prospective Registry of EoSinophilic esOphagitis
An observational study of Eosinophilic Esophagitis, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Eosinophilic Esophagitis
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 31 Dec 2044
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: EoE patients with a definite diagnosis according to the recent guidelines: >15 eos HPF as peak eosinophils count in at least 1 esophageal location in presence of symptoms of esophageal disfunction, undergoing various treatment and subsequent follow-up visits and endoscopies
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
- Being diagnosed with EoE as per guidelines of the disease
Who cannot join
- No clear diagnosis of EoE
- Not willing to provide informed consent to the inclusion in the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, Lombardy, 20132
Alberto Barchi, Medical Doctor, +3902.26432643, barchi.alberto@hsr.it
Alberto Barchi, Medical Doctor
About this study
Official title: Prospective Registry of EoSinophilic esOphagitis (PRESO)
This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute
Read the detailed description
Primary objective of the study is to create a registry of all EoE patients with > 18 years of age referring to the Motility and EoE Unit of San Raffaele Hospital, in order to register clinical, endoscopic and histologic data on the disease, to further design and propose future prospective or retrospective studies to increase disease knowledge and foster collaborations with other centers nationally and internationally
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Eosinophilic Esophagitis
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eosinophilic EsophagitisOther
Eosinophilic Esophagitis patients with a proper diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The prospective collection of histologic, endoscopic and clinical data on EoE patients
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Barchi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443346
- Sponsor's protocol ID
- PRESO
- Acronym
- PRESO
- Status last verified
- Jul 2025
- First submitted
- 30 May 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863.
PubMed 26488694Arias A, Perez-Martinez I, Tenias JM, Lucendo AJ. Systematic review with meta-analysis: the incidence and prevalence of eosinophilic oesophagitis in children and adults in population-based studies. Aliment Pharmacol Ther. 2016 Jan;43(1):3-15. doi: 10.1111/apt.13441. Epub 2015 Oct 28.
PubMed 26510832Mansoor E, Cooper GS. The 2010-2015 Prevalence of Eosinophilic Esophagitis in the USA: A Population-Based Study. Dig Dis Sci. 2016 Oct;61(10):2928-2934. doi: 10.1007/s10620-016-4204-4. Epub 2016 Jun 1.
PubMed 27250980Dellon ES, Peery AF, Shaheen NJ, Morgan DR, Hurrell JM, Lash RH, Genta RM. Inverse association of esophageal eosinophilia with Helicobacter pylori based on analysis of a US pathology database. Gastroenterology. 2011 Nov;141(5):1586-92. doi: 10.1053/j.gastro.2011.06.081. Epub 2011 Jul 14.
PubMed 21762663Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.
PubMed 25017104Ma C, Schoepfer AM, Safroneeva E; COREOS Collaborators; COREOS Collaborators. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus. Gastroenterology. 2021 Sep;161(3):748-755. doi: 10.1053/j.gastro.2021.04.080. Epub 2021 May 20. No abstract available.
PubMed 34022180Hahn JW, Lee K, Shin JI, Cho SH, Turner S, Shin JU, Yeniova AO, Koyanagi A, Jacob L, Smith L, Fond G, Boyer L, Lee SW, Kwon R, Kim S, Shin YH, Rhee SY, Moon JS, Ko JS, Yon DK, Papadopoulos NG. Global Incidence and Prevalence of Eosinophilic Esophagitis, 1976-2022: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3270-3284.e77. doi: 10.1016/j.cgh.2023.06.005. Epub 2023 Jun 17.
PubMed 37331411
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of EoSinophilic esOphagitis (PRESO)
- ClinicalTrials.gov ID
- NCT06443346
- Acronym / sponsor ID
- PRESO / PRESO
- Conditions
- Eosinophilic Esophagitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2044 (estimated)
- First posted
- 5 Jun 2024 (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.
This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute
Detailed description
Primary objective of the study is to create a registry of all EoE patients with > 18 years of age referring to the Motility and EoE Unit of San Raffaele Hospital, in order to register clinical, endoscopic and histologic data on the disease, to further design and propose future prospective or retrospective studies to increase disease knowledge and foster collaborations with other centers nationally and internationally
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- EoE patients with a definite diagnosis according to the recent guidelines: >15 eos HPF as peak eosinophils count in at least 1 esophageal location in presence of symptoms of esophageal disfunction, undergoing various treatment and subsequent follow-up visits and endoscopies
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
- Being diagnosed with EoE as per guidelines of the disease
Key exclusion criteria (2 listed)
- No clear diagnosis of EoE
- Not willing to provide informed consent to the inclusion in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eosinophilic EsophagitisEosinophilic Esophagitis patients with a proper diagnosis | Other | – |
Primary outcome
The prospective collection of histologic, endoscopic and clinical data on EoE patients
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 26488694Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863.
- Background: PubMed 26510832Arias A, Perez-Martinez I, Tenias JM, Lucendo AJ. Systematic review with meta-analysis: the incidence and prevalence of eosinophilic oesophagitis in children and adults in population-based studies. Aliment Pharmacol Ther. 2016 Jan;43(1):3-15. doi: 10.1111/apt.13441. Epub 2015 Oct 28.
- Background: PubMed 27250980Mansoor E, Cooper GS. The 2010-2015 Prevalence of Eosinophilic Esophagitis in the USA: A Population-Based Study. Dig Dis Sci. 2016 Oct;61(10):2928-2934. doi: 10.1007/s10620-016-4204-4. Epub 2016 Jun 1.
- Background: PubMed 21762663Dellon ES, Peery AF, Shaheen NJ, Morgan DR, Hurrell JM, Lash RH, Genta RM. Inverse association of esophageal eosinophilia with Helicobacter pylori based on analysis of a US pathology database. Gastroenterology. 2011 Nov;141(5):1586-92. doi: 10.1053/j.gastro.2011.06.081. Epub 2011 Jul 14.
- Background: PubMed 25017104Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.
- Background: PubMed 34022180Ma C, Schoepfer AM, Safroneeva E; COREOS Collaborators; COREOS Collaborators. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus. Gastroenterology. 2021 Sep;161(3):748-755. doi: 10.1053/j.gastro.2021.04.080. Epub 2021 May 20. No abstract available.
- Background: PubMed 37331411Hahn JW, Lee K, Shin JI, Cho SH, Turner S, Shin JU, Yeniova AO, Koyanagi A, Jacob L, Smith L, Fond G, Boyer L, Lee SW, Kwon R, Kim S, Shin YH, Rhee SY, Moon JS, Ko JS, Yon DK, Papadopoulos NG. Global Incidence and Prevalence of Eosinophilic Esophagitis, 1976-2022: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3270-3284.e77. doi: 10.1016/j.cgh.2023.06.005. Epub 2023 Jun 17.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Esophagitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis
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.
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 Eosinophilic Esophagitis, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Barchi, MD (3348630784, barchi.alberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prospective collection of histologic, endoscopic and clinical data on EoE patients (time frame: 10 years). 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 NCT06443346, which also lists 7 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 30 Jul 2025.