ClinicalTrials.gg
RecruitingNCT07614633Updated Jun 29, 2026

Natural History of Eosinophilic Esophagitis in Adult and Pediatric Population

An observational study in Eosinophilic Esophagitis (EoE), sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 2 sites in Italy. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
5 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 21 studies in Eosinophilic Esophagitis with a site in Italy — 8 open to participants now, 11 under way, 1 of them phase 3. Eosinophilic Esophagitis · Italy.

Planned enrollment
6th of 12
200 · median 153
Started
2025
with 1 other
Observational
12 of 21
8 open now
Primary completion
2027-12
later than 8 of 10 live
Registered
20th of 21
by date
Lead sponsor
2 of 21
Fondazione IRCCS Policlinico San Matteo di Pavia

Among the 21 studies in Eosinophilic Esophagitis with a site in Italy, this one is the 6th largest by planned enrollment of the 12 observational ones that give a count, is one of 2 that started in 2025, is one of 12 observational ones, reaches primary completion later than 8 of the 10 other live ones, and was the 20th registered.

Eosinophilic Esophagitis

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

Browse Eosinophilic Esophagitis studies →

Open to participants now

8 of the 21 studies in Eosinophilic Esophagitis with a site in Italy are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.

This study: 5 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Eosinophilic Esophagitis with a site in Italy, or all of them as a file.
02

Study summary

Eosinophilic esophagitis (EoE) is a Th2-mediated disease induced by ingestion of ambiental and alimentary allergens. Incidence of EoE is increasing in recent years. Young male subjects are more often affected by EoE. Esophageal eosinophilic infiltrate causes different symptoms of esophageal dysfunction (i.e. dysphagia, food impaction, chest pain, heartburn). In pediatric population symptoms are nonspecific (failure to thrive, vomiting) and more common to be misdiagnosed.

Symptoms are commonly sporadic and underestimated by the patients. Therefore, specialistic evaluations are often delayed during the following months and years. Moreover, esophageal symptoms are often not investigated or associated with other diseases especially in pediatric population (i.e. gastroesophageal reflux disease). For this reason, diagnosis of EoE is often delayed. It is known from literature that diagnostic delay in EoE causes prolonged inflammation of the esophagus that may lead to esophageal fibrosis and stenosis with worsening of symptoms. Proton pump inhibitors (PPIs) and topical steroids are the first line medicines to induce EoE remission. Prolonged clinical remission is described in 60% of adult patients with PPIs. Recently orodispersible budesonide showed clinical remission after 1 year nearby in 90% of adult patients. Orodispersible budesonide is effective also in chidren with an efficacy in maintaining remission at lowest effective dosage after 60 weeks in around 78% of patients. Dysphagia Symptom Questionnaire (DSQ) is a validated tool used in order to measure clinical activity (dysphagia) in adult and pediatric patients with EoE. Italian version of the DSQ is not available in literature. Little is known in literature about the natural history of EoE patients, in particular about sustained clinical remission and appearance of complications (i.e. food impaction) during a prolonged follow-up period. Aim of our two-phase prospective study is to evaluate the clinical and endoscopic response at the current available therapies and the appearance of complications during a prolonged follow-up period in a cohort of adult and pediatric population.

Read the detailed description

Two phases multicentre prospective observational study. In the first phase of the study, the Italian version of DSQ will be validated. In the second phase of the study, the clinical outcome of EoE patients will be investigated. Patients enrolled in the first phase will also enter in the second phase. For exploratory aim, serum and oesophageal tissue samples will be collected only in patient enrolled in S. C. General MedicineI.

03

Conditions studied

  • Eosinophilic Esophagitis (EoE)

Keywords

  • NATURAL HISTORY
  • Eosinophilic Esophagitis (EoE)
  • Dysphagia Symptom Questionnaire
04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Eosinophilic esophagitis patients who will access to the Endoscopy unit or to the Clinic "Medicina Generale 1" and to the others involved Centers will be consecutively enrolled.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with an established diagnosis of Eosinophilic esophagitis;
  • aged ≥5 years;
  • who gave written .

Exclusion criteria

Exclusion Criteria:

  • under 5 years old;
  • Patients who are illiterate;
  • Patients who are unwilling to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Adult cohort

    Adult cohort

  • Paediatric cohort

    Paediatric cohort

06

What researchers measure

Primary outcomes

  1. To evaluate the repeatability (test-retest reliability) of the Italian version of DSQ questionnaire at enrollment and at 1 months afterwards.

    The Intraclass correlation coefficient (ICC) will be calculated to evaluate the test-retest reliability of the Italian version of DSQ questionnaire.

    Time frame: 1 months afterwards the enrollment

Secondary outcomes

  1. Maintenance of remission in the follow-up period in both in EoE adult and paediatric patients.

    To calculate the cumulative proportion of maintenance of remission in the follow-up period will be estimated using Kaplan-Meier failure estimator both in EoE adult and paediatric patients.

    Time frame: every year for 5 years total

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2027, 27 months after the start.

Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 27 months is below that.

Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2026
First posted
May 29, 2026
StartActual
Sep 1, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07614633
Responsible party
Antonio Di Sabatino (Head of General Medicine I Unit, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
May 29, 2026
Start date
Sep 1, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 29, 2026

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion