An observational study in Peanut Allergy, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 5 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by University Hospital, Montpellier · Observational
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 2,000 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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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)
Exclusion criteria:
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.
Time frame: 24 months
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.
Time frame: 24 months
Plan to share: Undecided — NC
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This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier