Prospective Registry of EoSinophilic esOphagitis (PRESO)

July 28, 2025 updated by: Alberto Barchi, IRCCS San Raffaele

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lombardia
      • Milan, Lombardia, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele
        • Contact:
        • Principal Investigator:
          • Alberto Barchi, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The prospective collection of histologic, endoscopic and clinical data on EoE patients
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2044

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRESO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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