Food Protein-induced Enterocolitis Syndrome (FPIES) in 14 Children

August 29, 2018 updated by: Central Hospital, Nancy, France

Food protein-induced enterocolitis syndrome (FPIEES) is a particular non-Immunoglobulin E-mediated food allergy.

A retrospective descriptive single-center study was conducted. Subjects included were children with acute FPIES who consulted the allergy department of the Nancy Regional University Hospital between November 2013 and June 2016.

Study Overview

Status

Completed

Conditions

Detailed Description

As it is a descriptive study, the Primary Outcome is not a Measure. Therefore it is not possible to include the name of the measurement or measurement tool used to assess the measure in the primary outcome measure title.

Study Type

Observational

Enrollment (Actual)

14

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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with acute FPIES who consulted the allergy oupatient clinic of the Nancy Regional University Hospital between November 2013 and June 2016.

Description

Inclusion Criteria:

  • Child from 0 to 17 years with acute FPIES

Exclusion Criteria:

-

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms due to FPIES
Time Frame: from november 2013 to june 2016
description of symptoms due to acute FPIES and chronic FPIES
from november 2013 to june 2016

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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)

November 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 24, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2016-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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