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The Quality of Life of Mothers of Children With IgE-mediated Food Allergy

Study Purpose

Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed. Prevalence, persistence and severity of pediatric FA have significantly increased over the past 2 decades. The treatment of FA is based on a rigorous elimination diet and on the correct management of acute allergic reactions, induced by the accidental ingestion of food allergens, with antihistamines, cortisones and adrenaline. Ensuring a strict exclusion of the allergen from the diet can be problematic, with the risk of nutritional deficiencies, accidental exposure, cross-contamination or caused by incorrect labeling of processed food products. At the same time, the daily management of a correct elimination diet and a possible allergic reaction, entail a significant burden and high levels of anxiety and stress associated with uncertainty about the management of anaphylaxis, in the parents of children with FA, particularly in mothers, resulting in an impact on Quality of Life (QoL). The availability of a multidisciplinary team made up of pediatricians, allergists and dietitians / nutritionists with experience in the field of FA could reduce the stress and anxiety of parents, while improving their QoL. Currently, for the evaluation of the quality of life of the parent of a child with AF, specific questionnaires for food allergies developed and validated in English are used: the food allergy self-efficacy scale for parents (FASE-P) and the Food Allergy Quality of Life

  • - Parental Burden Questionnaire (FAQL-PB).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adult mother of a patient <12 years of age diagnosed with IgE-mediated FA.

Exclusion Criteria:

  • - Mother's age <18 years.
  • - Mother unable to understand Italian.
  • - Mother suffering from chronic diseases.
  • - Mother suffering from epilepsy.
  • - Mother suffering from neoplasms.
  • - Mother suffering from immunodeficiencies.
  • - Mother suffering from chronic infections.
  • - Mother suffering from autoimmune diseases.
  • - Mother suffering from inflammatory bowel diseases.
  • - Mother suffering from functional gastrointestinal disorders.
  • - Mother suffering from celiac disease.
  • - Mother suffering from genetic-metabolic diseases.
  • - Mother suffering from tuberculosis.
  • - Mother suffering from congenital heart disease.
  • - Mother suffering from tuberculosis.
  • - Mother suffering from cystic fibrosis.
  • - Mother suffering from other chronic pulmonary diseases.
  • - Mother suffering from major malformations.
  • - Mother suffering from previous surgery of the cardiovascular / respiratory / gastrointestinal tract.
  • - Mother suffering from diabetes.
  • - Mother suffering from neuropsychiatric and neurological disorders.
  • - Mother suffering from eosinophilic disorders of the gastrointestinal tract.
  • - Mother not living with her child with FA.
  • - Concomitant presence in the child with FA of chronic diseases.
  • - Concomitant presence in the child with FA of epilepsy.
  • - Concomitant presence in the child with FA of neoplasms.
  • - Concomitant presence in the child with FA of immunodeficiencies.
  • - Concomitant presence in the child with FA of chronic infections.
  • - Concomitant presence in the child with FA of autoimmune diseases.
  • - Concomitant presence in the child with FA of inflammatory bowel diseases.
  • - Concomitant presence in the child with FA of functional gastrointestinal disorders.
  • - Concomitant presence in the child with FA of celiac disease.
  • - Concomitant presence in the child with FA of genetic-metabolic diseases.
  • - Concomitant presence in the child with FA of tuberculosis.
  • - Concomitant presence in the child with FA of congenital heart disease.
  • - Concomitant presence in the child with FA of tuberculosis.
  • - Concomitant presence in the child with FA of cystic fibrosis.
  • - Concomitant presence in the child with FA of other chronic lung diseases.
  • - Concomitant presence in the child with FA of major malformations.
  • - Concomitant presence in the child with FA of previous surgeries of the cardiovascular / respiratory / gastrointestinal tract.
  • - Concomitant presence in the child with FA of diabetes.
  • - Concomitant presence in the child with FA of neuropsychiatric and neurological disorders.
  • - Concomitant presence in the child with FA of eosinophilic diseases of the gastrointestinal tract.
  • - Concomitant presence in the child with FA of allergic diseases other than FA.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04740632
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Federico II University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy
Arms & Interventions

Arms

: Mothers of children with IgE-mediated food allergy diagnosed by a multidisciplinary team

Mothers of children with IgE-mediated FA diagnosed for at least 6 months who plan to visit a specialized level III center for the management of pediatric FA for the first time

: Mothers of children with IgE-mediated food allergy diagnosed by a non-multidisciplinary team

Mothers of children with IgE-mediated AA diagnosed for at least 6 months who plan to undergo a follow-up visit at a specialized level III center for the management of FA in pediatric age which they have already been followed for at least 6 months

Interventions

Behavioral: - Assessment of the quality of life of mothers of children with IgE-mediated food allergy

Questionnaire on the demographic characteristics of the mother; The food allergy self-efficacy scale for parents (FASE-P); The Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB); Food Allergy Quality of Life Questionnaire - Parent Form (children aged 0-12 years) (FAQLQ-PF)

Contact a Trial Team

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International Sites

Naples, Italy

Status

Recruiting

Address

Department of Traslational Medical Science - University of Naples Federico II

Naples, , 80131

Site Contact

Roberto Berni Canani, MD, PhD

berni@unina.it

0817462680

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