Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04643704 |
| Other study ID # |
APHP201063 |
| Secondary ID |
IDRCB 2020-A0201 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2021 |
| Est. completion date |
July 22, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
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
FPIES and IgE-mediated food allergies primarily affect young children. A limiting factor in
terms of age for this study is the fact that the Food Allergy Quality of Life Questionnaire
(FAQLQ) has not been translated into French for adolescents over 12 years old.
The population studied is therefore children under 12 years of age, with a diagnosis of
FPIES, IgE-mediated allergy or celiac disease. A control group is also planned to be
included.
1.3 Description of the elements covered by the study
. Quality of Life
Food allergies negatively impact the quality of life of patients and their families due to
prolonged and restrictive avoidance diet.
The quality of life of children with celiac disease does not differ from that of healthy
children.
In our experience, parents of patients with FPIES often report fear of another impressive
allergic reaction, with profuse vomiting, and a child described as lethargic and pale during
the reaction.
Parents sometimes prefer to delay entering the community in the face of fear of accidental
exposure to the culprit allergen, or the fear of a reaction with the introduction of new
food, especially if the child is already allergic to several groups of food.
The quality of life of families is more impaired in cases of FPIES than in cases of
IgE-mediated food allergy.
During childhood, there are 2 ways to assess the quality of life: a) by measuring the quality
of life of the child himself, or b) by measuring the quality of life of the child according
to the perception of parents.
The generic PedsQLTM quality of life questionnaire was validated in English and in French to
assess children's quality of life, using a form to be completed by parents from birth and /
or by the child after the age of 5.
Food allergy-specific quality of life questionnaires: FAQL-PB (Food Allergy Quality of
Life-Parental Burden) and FAQLQ-PF (Food Allergy Quality of Life Questionnaire - Parent Form)
have been validated for IgE-mediated food allergies and in FPIES in parents of children aged
0 to 12 in an English version. There is also a French version of FAQLQ-PF and FAQLQ-CF (Food
Allergy Quality of Life Questionnaire - Child Form).
To date, no quality of life study has been performed in a French-speaking pediatric
population with FPIES or celiac disease.
Eating disorders
Food neophobia is physiological between the ages of 2 and 6, but becomes pathologic if it
persists beyond 6 years or if it is exacerbated between 2 and 6 years. It is defined by a
refusal to eat foods which are new or not known by the child.
Although the majority of patients with FPIES are allergic to only one food, children's diets
are often over-restricted to several food groups.
Eating disorders affect 22 to 50% of children with FPIES. These are mainly food refusals,
swallowing or chewing difficulties, and sensory disturbance. The risk of food refusal is
increased in the event of multiple-food FPIES. In a cohort of 32 patients, only half of these
patients received a specialist opinion for the management of eating disorders, probably due
to default screening for these disorders.
The French Child Food Rejection Scale (CFRS) score allows screening for food neophobia and
pickiness in children aged 2 to 7.
For older children (over 7 years old) and adults, there is the Food Neophobia Scale (FNS),
adapted in French (AFNS: Adapted Food Neophobia Scale).
To date, no study has evaluated eating disorders in a French-speaking pediatric population
with FPIES or celiac disease.
1.4 Rationale for the duration of the study The research will last at least 2 years. The goal
is to include at least 100 patients with FPIES, 100 patients with IgE-mediated food allergy
other than FPIES, 100 patients with celiac disease and 100 control patients.
