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临床试验/NCT04643704
NCT04643704已完成不适用

Evaluation of Quality of Life and Eating Disorders in Children With Food Protein Induced Enterocolitis Syndrom, Food Allergy or Celiac Disease

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 403 人开始时间: 2021年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
403
试验地点
1
主要终点
Quality of life (QoL) in children with FPIES

研究概览

简要总结

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

详细描述

1.1 Current state of knowledge

IgE-mediated food allergies are allergies whose symptoms are urticaria, angioedema, rhinoconjunctivitis, digestive signs, bronchospasm, or even anaphylaxis within 2 hours after ingestion of food. The prevalence of these food allergies in children ranges from 1.6% to 5.6%. Patients with food allergy should follow a strict avoidance diet of the culprit food, until tolerance get acquired in a few months or years later. The avoidance diet is set up by the parents, and must be applied in all places where the child lives (family, nursery and school). Careful reading of the labels and displays in collective restorations are essential in order to limit accidental ingestion. For the most ubiquitous and / or risky foods, parents often have to provide packed lunches. An IgE-mediated emergency kit is required, containing an antihistamine, and sometimes a self-injectable epinephrine pen and bronchodilators. The protocol in the event of an allergic reaction must be known by all caregivers for the child, in order to react immediately if necessary.

Food protein-induced enterocolitis syndrome or FPIES is one of the non IgE-mediated forms of food allergy. Incidence is estimated around 0.015-0.7% in infants and children. FPIES symptoms are delayed: vomiting within 1 to 4 hours after ingestion of the offending food, associated with other symptoms such as lethargy with pallor, diarrhea secondarily. Unlike other non IgE-mediated allergies, FPIES is a potentially severe allergy, with hypovolemic shock seen in 15-33% of cases with dehydration. The most frequently offending foods are ubiquitous, such as milk, fish, eggs, rice and oats. The management of patients with FPIES consists of the avoidance of the offending food(s) until that tolerance is acquired spontaneously in a few months or years. A specific first aid kit is also prescribed, in order to limit dehydration in the event of vomiting after an accident of ingestion, with at least oral rehydration solution.

Celiac disease is a gluten-induced autoimmune enteropathy responsible for digestive malabsorption. It affects 1.4% of the population in the world. The symptoms are very varied, such as chronic diarrhea or chronic constipation resistant to laxative treatment, abdominal distension, chronic fatigue, weight loss and growth retardation, nutritional deficiencies. The treatment consists of a lifelong elimination of gluten only (strict for wheat, rye, barley, and controlled for oats). To date, celiac disease is not curable, but the elimination diet allows clinical, biological and histological normalization in the digestive mucosa. Unlike FPIES or IgE-mediated allergies, the patient and their family do not have to fear a severe reaction in case of accidental exposure, and no first aid kit is required.

1.2 Description of the population to be studied and justification of their choice

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Quality of life (QoL) in children with FPIES

时间窗: 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

次要结局

  • Food neophobia in children with celiac disease(24 months)
  • Food neophobia in children with FPIES(24 months)
  • QoL in children with celiac disease(24 months)
  • Food neophobia in children with food allergy(24 months)
  • Food neophobia in children without any food avoidance(24 months)
  • QoL in children with food allergy(24 months)
  • QoL in children without any food avoidance(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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