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RecruitingNCT06443346PRESOUpdated Jul 30, 2025

Prospective Registry of EoSinophilic esOphagitis

An observational study in Eosinophilic Esophagitis, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-07-30.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study 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 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

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Conditions studied

  • Eosinophilic Esophagitis
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In context

Eosinophilic Esophagitis

235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 84 across 86 observational studies indexed under Eosinophilic Esophagitis.

Browse Eosinophilic Esophagitis studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  1. Participant is willing and able to give informed consent for participation in the study.
  2. The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
  3. Being diagnosed with EoE as per guidelines of the disease

Exclusion criteria

Exclusion Criteria:

  1. No clear diagnosis of EoE
  2. Not willing to provide informed consent to the inclusion in the registry
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • OtherEosinophilic Esophagitis

    Eosinophilic Esophagitis patients with a proper diagnosis

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What researchers measure

Primary outcomes

  1. The prospective collection of histologic, endoscopic and clinical data on EoE patients

    Time frame: 10 years

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Study locations

1 of 1 sites recruiting
  • IRCCS San Raffaele
    Milan, Lombardy 20132, Italy
    • Alberto Barchi, Medical Doctor · Contact · barchi.alberto@hsr.it · +3902.26432643
    • Alberto Barchi, Medical Doctor · Principal investigator
    Recruiting
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References and documents

Publications

  • Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863. PubMed 26488694 ↗
  • Arias 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 26510832 ↗
  • Mansoor 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 27250980 ↗
  • Dellon 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 21762663 ↗
  • Kottyan 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 25017104 ↗
  • Ma 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 34022180 ↗
  • Hahn 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06443346
Lead sponsor
IRCCS San Raffaele
Responsible party
Alberto Barchi (Medical Doctor, IRCCS San Raffaele) — Principal investigator
First posted
Jun 5, 2024
Start date
Jun 1, 2024
Primary completion
Dec 31, 2034 (estimated)
Completion
Dec 31, 2044 (estimated)
Last update
Jul 30, 2025

Study contacts

Alberto Barchi, MD
Contact
barchi.alberto@hsr.it
3348630784

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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