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Oral Low Doses Tolerance INduction Study for Peanuts

NCT04881773 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2021-05-11

No results posted yet for this study

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

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Davide CAIMMI · University Hospital, Montpellier

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-01-01
Completion
2022-06-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881773 on ClinicalTrials.gov