Introduction Sesame allergy, though with low prevalence, can result in severe, potentially life-threatening reactions and poses challenges in allergen avoidance due to hidden sources. In the majority of patients, sesame allergy persists and there is currently no effective long-term treatment available. Therefore, oral immunotherapy (OIT) is a promising alternative approach to managing sesame allergy. In this study protocol, we present a randomised controlled trial evaluating the efficacy and safety of OIT with low-dose sesame protein in paediatric patients. The study’s aim is to compare OIT with a 300 mg maintenance dose of sesame protein against controls. Methods and analysis 39 participants aged 3–17 with IgE-mediated sesame allergy confirmed by oral food challenge will be enrolled into the study. The trial will be conducted at the Paediatric Hospital of the Medical University of Warsaw, Poland. The study comprises two arms—sesame OIT and control. In the sesame OIT group, interventions will be administered once daily for up to 18 months. During the first phase, the dose will be escalated every 2–4 weeks, and in the second phase, the maintenance dose of 300 mg sesame protein will continue for 3 months. Members of the control group will receive standard treatment, which includes an elimination diet and will remain under observation for 1 year. The primary outcome is the proportion of participants tolerating a single dose of 4000 mg of sesame protein during the final oral food challenge in the experimental group versus the control group. Secondary outcomes assess adverse events, changes in immunological parameters and the maximum tolerated doses of sesame protein in each group. Ethics and dissemination This study has been approved by the Ethics Committee of the Medical University of Warsaw (approval number: KB/269/2023). Results will be published in peer-reviewed journals and disseminated via presentations at international conferences. Trial registration number NCT06261554.
Peanut allergy, one of the most frequently occurring allergies, usually starts in childhood and rarely subsides—often persisting throughout adult life. Accidental exposure to peanuts can often result in adverse reactions ranging from mild to life-threatening, such as anaphylactic shock. Historically, food avoidance and the use of rescue drugs have remained a fundamental management mechanism for dealing with food allergy. However, prevention of adverse reactions to food allergy is playing an increasing role. This is possible through the early introduction of peanuts into the diet, especially in infants at risk of this allergy. In recent years, specific immunotherapy has been used to develop desensitisation and, in some patients, tolerance—defined as a persistent state of clinical non-reactivity to the allergen after therapy is finished. The aim of this article is to summarise the current state of knowledge on the prevention and treatment of peanut allergy, with a focus on clinical trials, current guidelines, and recent experimental studies. This review may be particularly useful for paediatricians and general practitioners.
(1) Peanut allergy is associated with high risk of anaphylaxis which could be prevented by oral immunotherapy. Patients eligible for immunotherapy are selected on the basis of a food challenge, although currently the assessment of antibodies against main peanut molecules (Ara h 1, 2, 3 and 6) is thought to be another option. (2) The current study assessed the relationship between the mentioned antibodies, challenge outcomes, skin tests and some other parameters in peanut-sensitized children. It involved 74 children, divided into two groups, based on their response to a food challenge. (3) Both groups differed in results of skin tests, levels of component-specific antibodies and peanut exposure history. The antibody levels were then used to calculate thresholds for prediction of challenge results or symptom severity. While the antibody-based challenge prediction revealed statistical significance, it failed in cases of severe symptoms. Furthermore, no significant correlation was observed between antibody levels, symptom-eliciting doses and the risk of severe anaphylaxis. Although in some patients it could result from interference with IgG4, the latter would not be a universal explanation of this phenomenon. (4) Despite some limitations, antibody-based screening may be an alternative to the food challenge, although its clinical relevance still requires further studies.
Aim: To compare safety and clinical outcomes of two different oral immunotherapy (OIT) maintenance doses (150 mg vs. 300 mg) of peanut protein in children with peanut allergy. Methods: This prospective study enrolled 44 children aged 4–17 years with confirmed peanut allergy. Following dose escalation, participants were allocated to receive either 150 or 300 mg of peanut protein daily for 8 weeks. Oral food challenges (OFCs) were conducted before and after OIT. The primary endpoint was the proportion of participants tolerating ≥ 300 mg of peanut protein post‐treatment. Secondary outcomes included changes in immunologic markers (skin prick tests wheal size, sIgE, IgG4) and safety. Results: Of the 44 enrolled children, 33 (75.0%) completed the full protocol. The primary outcome was achieved in 73.9% of the 150 mg group and 71.4% of the 300 mg group ( p = 0.853). Both regimens were associated with reductions in immunological parameters. Adverse events were mainly mild to moderate. Conclusion: Peanut OIT using either 150 mg or 300 mg maintenance doses was associated with increased tolerance thresholds and immunological changes in highly allergic children. These findings support the feasibility of OIT in real‐world clinical settings while highlighting the need for further multicentre research to determine optimal dosing strategies.