Prevalence and Description of FIRE (Food Induced Immediat... | NCT06972147

Studies
Prevalence and Description of FIRE (Food Induced Immediate Response of the Esophagus) in the Pediatric Population With Eosinophilic Esophagitis

NCT06972147

Sponsor

University Hospital, Angers

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Eosinophilic Esophagitis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CHU Angers	Other Identifier	CHU Angers

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Mar 14, 2025

First Submission Date that Met QC Criteria

May 6, 2025

First Posted Date

May 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A new clinical entity of eosinophilic esophagitis, Food Induced Immediate Response of the Esophagus or FIRE, has been described since 2020. Diagnostic criteria are not clearly established. Specific questioning is necessary for differential diagnosis, such as the oro-pharyngeal syndrome notably described in pollinics, or a mechanical blockage strictly speaking linked to esophagitis. The aim is to obtain epidemiological data on this entity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
eosinophilic esophagitis		questionnary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnosis of FIRE syndrome	symptoms such as pain, pressure, choking or narrowing, in the oesophagus or retrosternum, within 10 minutes of ingestion, lasting a maximum of 120 minutes, when a specific food is ingested	day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients over 6 and under 18 years of age at the time of inclusion
Follow-up in the allergology unit of Angers University Hospital for eosinophilic esophagitis

Exclusion Criteria:

Patients or legal representative with severe communication or language comprehension difficulties
Patients or legal representatives objecting to study participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Patient follow-up in the allergology unit of Angers University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne HOPPE, MD	Contact	241353637	+33	anne.hoppe@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Anne HOPPE	University Hospital of Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HOPPE Anne	Recruiting	Angers			France
CHU Lille

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057765	Eosinophilic Esophagitis

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided