Oral Low Doses Tolerance INduction Study for Peanuts

Peanut Allergy Clinical Trial

— OLDTINYpeanut  

Official title:

Oral Low Doses Tolerance INduction Study for Peanuts

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04881773
• Other study ID #: RECHMPL21_0254
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: June 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients experiencing side effects during OIT	Percentage of patients experiencing side effects during OIT (classified on the basis of their severity); percentage of patients in whom the tolerated dose of PP could be doubled and tripled, compared to the eliciting dose, assessed during an oral food challenge before the beginning of the OIT; percentage of patients who achieve a tolerated dose of 300 mg of PP and 1000 mg of PP during OIT. By doing a subgroup analysis, we will evaluate the same results in patients with a clinical history of grade 2 or grade three anaphylaxis to peanuts.	24 months