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Quality of Life and Eating Disorders in Children With FPIES, Food Allergy or Celiac Disease (QUALIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643704
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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


Condition or disease
FPIES IgE Mediated Food Allergy Celiac Disease

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Quality of Life and Eating Disorders in Children With Food Protein Induced Enterocolitis Syndrom, Food Allergy or Celiac Disease
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Group/Cohort
FPIES
100 patients
IgE mediated food allergy
100 patients
Celiac disease
100 patients
Control group
100 patients



Primary Outcome Measures :
  1. Quality of life (QoL) in children with FPIES [ Time Frame: 12 months ]
    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


Secondary Outcome Measures :
  1. Food neophobia in children with FPIES [ Time Frame: 24 months ]
    CFRS (Child Food Rejection Scale) for children with FPIES from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children with FPIES from 8 to 12 years old

  2. QoL in children with food allergy [ Time Frame: 24 months ]
    FAQLQ-PF for parents of children from 0 to 12 years old with IgE-mediated food allergy FAQLQ-CF for children between 8 to 12 years old with IgE-mediated food allergy PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with IgE-mediated food allergy

  3. QoL in children with celiac disease [ Time Frame: 24 months ]
    : generic questionnaire of QoL for parents and children from 0 to 12 years old with IgE-mediated food allergy PedsQLTM child form: generic questionnaire of QoL for children from 5 to 12 years old

  4. QoL in children without any food avoidance [ Time Frame: 24 months ]
    PedsQLTM: generic questionnaire of QoL for parents and children from 0 to 12 years old with IgE-mediated food allergy PedsQLTM child form: generic questionnaire of QoL for children from 5 to 12 years old

  5. Food neophobia in children with food allergy [ Time Frame: 24 months ]
    CFRS (Child Food Rejection Scale) for children from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children from 8 to 12 years old

  6. Food neophobia in children with celiac disease [ Time Frame: 24 months ]
    CFRS (Child Food Rejection Scale) for children from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children from 8 to 12 years old

  7. Food neophobia in children without any food avoidance [ Time Frame: 24 months ]
    CFRS (Child Food Rejection Scale) for children from 2 to 7 years old AFNS (Adapted Food Neophobia Scale) for children from 8 to 12 years old



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

General exclusion criteria:

  • 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

Criteria for non-inclusion in the "FPIES" group:

  • Patient with mixed FPIES with associated IgE-mediated symptomatology
  • Non IgE-mediated food allergies other than FPIES

Criteria for non-inclusion in the "celiac disease" group:

- Patient with hypersensitivity to non-celiac gluten

Criteria for non-inclusion in the "control" group:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643704


Contacts
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Contact: Anaïs Lemoine, MD (+33) 01 44 73 60 69 anais.lemoine@aphp.fr

Locations
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France
Trousseau Hospital, Service : Nutrition et Gastroentérologie Pédiatrique Recruiting
Paris, France
Contact: Anais Lamoine, MD    01 71 73 82 83    anais.lemoine@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Anaïs Lemoine Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04643704    
Other Study ID Numbers: APHP201063
IDRCB 2020-A02017-32 ( Other Identifier: ANSM )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Quality of life
Food avoidance
restriction
Food allergy
Feeding disorder
Psychology
Additional relevant MeSH terms:
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Celiac Disease
Hypersensitivity
Food Hypersensitivity
Feeding and Eating Disorders
Immune System Diseases
Mental Disorders
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Hypersensitivity, Immediate