An interventional study of High dose of peanuts and Low dose of peanuts in Peanut Allergy, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.
Peanut allergy is a significant clinical problem. Food immunotherapy provides the latest approach to managing food allergy. Oral immunotherapy is considered as the most effective and safe, according to current research. What is more, this type of therapy is easily available and can be continued at patient's home. Obtaining and maintenance of tolerance to the allergic food is the main goal of this procedure.
The study will include children with peanut allergy, confirmed during open oral food challenge (OOFC) with peanut protein. First OOFC will be performed before immunotherapy, second one at the end of procedure. Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of peanut protein, which amounts 150mg, the second will get high dose, which is 300 mg of peanut protein. Oral immunotherapy with low and high dose of peanut protein in children randomly assigned to two groups (1:1).
In the following phase, every two weeks the dose of ground roasted peanut will be increased and applied to a child during hospitalization (1-day procedure). Precondition to increase of dose is good tolerance of previous portion of peanut. The maximum time frame for this phase is 14 months.
After achieving tolerance, immunotherapy will be continued for 2 months in maintenance phase, with dose 150mg or 300 mg peanut protein, depending on a study group.
The dosage increasing phase will last maximally 14 months. If patients achieves the maintenance dose earlier, this period may be shorter. Maintenance dose is determined by random patients' assignment to one from study's group and amounts 150mg or 300 mg of peanut protein, respectively.
The duration of the maintenance phase is 8 weeks (+/-2 weeks). After 2 months (8 weeks +/-2 weeks) of maintenance dose the final OOFC and evaluation of tolerance of peanut protein will be performed. Confirmation of the total desensitization of peanut is the tolerance of a single dose of 4500 mg peanut protein.
152 studies on the registry are indexed under Peanut Hypersensitivity; 29 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 117 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
medication:
20 patients
Dietary Supplement: High dose of peanuts
20 patients
Dietary Supplement: Low dose of peanuts
Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
Tolerance of peanuts
Proportion of participants who tolerate the single dose of 300 mg or more (maximum 4500mg) peanut protein
Time frame: Up to 16 months after starting oral immunotherapy
Adverse event
quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category
Time frame: Up to 16 months after starting oral immunotherapy
Laboratory data
difference in peanut serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment
Time frame: Up to 16 months after starting oral immunotherapy
Skin prick test (SPT)
change in skin prick test reactivity to peanut protein from baseline to end of treatment, compared between groups
Time frame: Up to 16 months after starting oral immunotherapy
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw