Clinical trial NCT04881773: Oral Low Doses Tolerance INduction Study for Peanuts
Official title: Oral Low Doses Tolerance INduction Study for Peanuts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peanut Allergy
Keywords: Food allergy
peanuts
Oral Immunotherapy
efficacy
safety
Peanut IgE mediated allergy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older that 5 years of age, with a diagnosis of IgE mediated peanuts allergy, undergoing a oral immunotherapy protocol for peanuts, at the University Hospital of Montpellier (France)

Brief summary: Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.

To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.


Eligibility criteria: Inclusion criteria:

* Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
* Patients aged 5 years or older;
* Patients with a history of immediate reaction after consuming peanuts
* AND a positive peanut prick test;
* AND peanut positive specific serum IgE (ImmunoCAP®);
* AND a positive oral peanut challenge test OR a clinical history of anaphylaxis AND peanut-specific IgE\> 100 kUA / L (ImmunoCAP®);
* Patients who started peanut OIT between September 2018 and January 2021.

Exclusion criteria:

* Patients in exclusion period determined by a previous study;
* Patients under legal protection, under guardianship or under curatorship;
* Possible poor therapeutic compliance to the OIT protocol;
* Active malignant neoplasia or autoimmune disease;
* Active eosinophilic esophagitis or other gastrointestinal eosinophilic disorders;
* Severe active eczema;
* Pregnancy ;
* Cardiovascular disease and use of beta blockers and / or ACE inhibitors;
* Chronic urticaria;
* Mastocytosis.

Primary outcomes:
measure: Percentage of patients who reach a tolerated dose
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of patients experiencing side effects during OIT
timeFrame: 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Davide CAIMMI
role: STUDY_DIRECTOR
References: