CompletedNot Applicable

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

France403 participantsStarted 2021-01-05

Plain-language 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

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of life (QoL) in children with FPIES

Timeframe: 12 months

Trial details

NCT IDNCT04643704

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-07-22

View on ClinicalTrials.gov More FPIES trials