Oral Low Doses Tolerance INduction Study for Peanuts (NCT04881773) | Clinical Trial Compass
UnknownNot Applicable
Oral Low Doses Tolerance INduction Study for Peanuts
France2,000 participantsStarted 2018-09-01
Plain-language 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.
Who can participate
Age range
5 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.