NCT04881773

Oral Low Doses Tolerance INduction Study for Peanuts

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 5 Years – 65 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2018-09-01
• Primary completion: 2021-01-01
• Completion: 2022-06-01
• First posted: 2021-05-11
• Last updated: 2021-05-11

Locations

1 site across 1 country: France