Oral Low Doses Tolerance INduction Study for Peanuts

NCT ID: NCT04881773

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2022-06-01

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.

Conditions

Peanut Allergy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davide CAIMMI

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Uhmontpellier

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL21_0254

Identifier Type: -

Identifier Source: org_study_id