Oral Low Doses Tolerance INduction Study for Peanuts

NCT04881773 | Unknown

• 1 other identifier: RECHMPL21_0254
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Keywords

Food allergy; peanuts; Oral Immunotherapy; efficacy; safety; Peanut IgE mediated allergy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who reach a tolerated dose

  Percentage of patients who reach a tolerated dose of 2000 mg of PP during the ITO and percentage of patients who reach a cumulative tolerated dose of 4400 mg of PP during the oral challenge, carried out at least 6 month after the end of the ITO.

  24 months

Secondary Outcomes (1)

• Percentage of patients experiencing side effects during OIT

  24 months

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Davide CAIMMI

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 11, 2021
• Study Start: September 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

FR (1)