NCT04643704

Brief Summary

Food allergies are associated with a decrease in quality of life. Patients with FPIES often have more food avoidance than necessary. The greater the number of avoided foods, the greater the risk of eating disorders. To date, no study about quality of life or assessment of eating difficulties has been performed in a French-speaking pediatric population with FPIES or celiac disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

November 19, 2020

Last Update Submit

September 26, 2022

Conditions

FPIESIgE Mediated Food AllergyCeliac Disease

Keywords

Quality of lifeFood avoidancerestrictionFood allergyFeeding disorderPsychology

Outcome Measures

Primary Outcomes (1)

  • Quality of life (QoL) in children with FPIES

    FAQLQ (Food Allergy Quality of Life Questionnaire)-PF (Parent form) for parents of children from 0 to 12 years old with FPIES FAQLQ-CF (Child Form) for children between 8 to 12 years old with FPIES PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with FPIES

    12 months

Secondary Outcomes (7)

  • Food neophobia in children with FPIES

    24 months

  • QoL in children with food allergy

    24 months

  • QoL in children with celiac disease

    24 months

  • QoL in children without any food avoidance

    24 months

  • Food neophobia in children with food allergy

    24 months

  • +2 more secondary outcomes

Study Arms (4)

FPIES

100 patients

IgE mediated food allergy

100 patients

Celiac disease

100 patients

Control group

100 patients

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients recruited from hospitalization (conventional, and day-care unit) and consultation. Healthy controls without any food avoidance recruited from consultations, hospitalisations or community. Multicentric study * Pediatric Nutrition and Gastroenterology Unit - Trousseau Hospital, APHP; * Pediatric Pneumology and Allergy Unit - Necker-Enfants Malades Hospital, APHP; * Pediatric department and Asthma and Allergy unit - Ambroise Paré Hospital, APHP.

You may qualify if:

  • Any patient from 0 to 12 years of age, with FPIES or an IgE-mediated food allergy or celiac disease.
  • Controls: chid from 0 to 12 years old, without any food avoidance for medical reason, and without chronical severe pathology

You may not qualify if:

  • Families and patients who do not understand French
  • Cured food allergy (FPIES, IgE or non IgE-mediated food allergy)
  • Allergic patient (FPIES, IgE-mediated food allergy) undergoing oral or epicutaneous tolerance induction
  • Patient with mixed FPIES with associated IgE-mediated symptomatology
  • Non IgE-mediated food allergies other than FPIES
  • \- Patient with hypersensitivity to non-celiac gluten
  • Current food avoidance, personal or in one of the household members due to allergy, or digestive disorders (abdominal pain, diarrhea for example) induced by the consumption of particular foods and requiring a strict avoidance diet
  • Chronic digestive pathology (chronic inflammatory bowel disease, functional bowel disorders with a correlation of symptoms with diet, esophagitis and eosinophilic enteropathy)
  • Chronic nutritional, metabolic or endocrine pathologies for which diet can have an impact: obesity, dyslipidemia, diabetes
  • Severe chronic respiratory pathology (eg: cystic fibrosis, chronic respiratory failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trousseau Hospital, Service : Nutrition et Gastroentérologie Pédiatrique

Paris, France

Location

MeSH Terms

Conditions

Food HypersensitivityCeliac DiseaseFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System DiseasesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Anaïs Lemoine

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

November 25, 2020

Study Start

January 5, 2021

Primary Completion

July 22, 2022

Study Completion

July 22, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Locations

FR(1)