Skip to main content
Clinical Trials/NCT04881773
NCT04881773UnknownNot Applicable

Oral Low Doses Tolerance INduction Study for Peanuts

University Hospital, Montpellier1 site in 1 country2,000 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
2,000
Locations
1
Primary Endpoint
Percentage of patients who reach a tolerated dose

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
5 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of patients who reach a tolerated dose

Time Frame: 24 months

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.

Secondary Outcomes

  • Percentage of patients experiencing side effects during OIT(24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials