Immunosuppression is associated with an increased risk of delayed SARS-CoV-2 viral clearance, severe COVID-19 and related death. This heterogeneous group of affected patients includes but is not limited to those with a haematological malignancy, people on immunosuppressive therapy for the treatment of autoimmune/inflammatory diseases and those following bone marrow transplantation (BMT). Immunosuppression is associated with decreased rates of anti-spike IgG seroconversion following COVID-19 vaccination. While clinical guidelines have been established to guide vaccination pre-splenectomy and post-BMT, there are limited data to guide timing of COVID-19 or other booster vaccines in adults commencing new or intensified moderate to severe immunosuppression. The comparison of immunity-boosting regimens for COVID-19 upon initiation of immunosuppressive therapy (CIRCUIT) study was designed to address this knowledge gap. CIRCUIT investigates whether administration of a third (or subsequent) COVID-19 booster vaccine ≤2 weeks prior to immunosuppression provides greater anti-spike IgG-mediated immunity than a booster given 24 weeks after new or intensified immunosuppression, that is, week 24 timepoint (Group 1; n=280). Additionally, the research will investigate whether giving a fourth post-BMT COVID-19 booster vaccine at 9 months post-transplant provides greater anti-spike IgG-mediated immunity than a booster given 15 months post-transplant (Group 2; n=40).

The CIRCUIT study is an open-label, multicentre randomised clinical trial. Participants will be randomised 1:1 to receive either an additional COVID-19 booster ≤2 weeks pre-immunosuppression and a diphtheria/tetanus toxoids (DT) booster at 24 weeks following new or intensified immunosuppression (week 24 timepoint) or receive a DT booster ≤2 weeks pre-immunosuppression and an additional COVID-19 booster at week 24 (Group 1). Group 2 participants who underwent autologous or allogenic BMT in the last 9 months will be randomised 1:1 to either receive a fourth post-BMT COVID-19 booster at 9 or 15 months post-transplant. The primary outcome will be the integrated time-weighted area under the curve anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months from a SARS-CoV-2 booster as assessed by a high-throughput SARS-CoV-2 NAb platform assay. Key secondary outcomes of the CIRCUIT randomised control trial will include safety and generation of SARS-CoV-2 antigen specific T and B cell responses.

The research protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee on 25 August 2022 (Ref no. 2022/PID00782 – 20022/ETH0069). Study results will be published in peer-reviewed medical journals and presented at local and international conferences. All findings regardless of the outcome will be reported.

NCT05415267.

Allergic rhinitis (AR) is a highly prevalent condition worldwide and imposes a substantial public health burden on adults. Although Traditional Chinese Medicine (TCM) therapies have shown potential therapeutic benefits in AR management, the lack of a standardised outcome evaluation framework limits evidence comparability and synthesis. Current studies commonly exhibit inconsistent outcome selection, heterogeneous measurement instruments and unclear assessment time points, reducing the applicability of findings to evidence-based practice and guideline development. Moreover, existing AR-related core outcome set (COS) studies generally target a broad population, with limited focus on adults (aged 18–75 years) and insufficient involvement of patients and other stakeholders. Therefore, this study aims to establish a standardised COS for clinical research in adult allergic rhinitis (COS-AR), with clearly defined outcomes, measurement instruments and recommended assessment time points. This COS-AR will provide a framework for outcome selection and measurement in clinical studies of TCM for adult AR.

The development of COS-AR will be conducted in four sequential phases: (1) A comprehensive review of randomised controlled trials and clinical trial registry entries related to adult AR from major domestic and international databases published between 1 January 2019 and 31 August 2025 will be performed. This phase will involve the systematic categorisation of all reported outcomes, including their definitions, measurement instruments and assessment time points. (2) An online survey will be administered to both clinicians and patients involved in AR management to identify outcomes considered most important by these stakeholders. (3) A modified Delphi process, consisting of two to three rounds of online surveys, will be conducted with over 100 key stakeholders to establish a COS. (4) One or two online consensus meetings will be convened with a representative group of 20–30 key stakeholders to reach final consensus on the outcomes, their definitions, measurement instruments and recommended assessment time points to be included in the COS-AR.

All activities conducted in this study have received ethical approval from the Medical Ethics Committee of Zhejiang Hospital (Ethics Approval Number: 2023 (9K)-X4). Written informed consent will be obtained from all participants prior to participation. The research findings will be disseminated through peer-reviewed publications and relevant academic and professional conferences.

China Clinical Trial Core Outcome Sets Research Centre (ChiCOS). Available at: https://www.chicos.org.cn/cos/1788748723768049665 (accessed 29 December 2025)

Anaphylaxis is a sudden onset multiorgan allergic reaction that infrequently but regularly causes fatalities which may be preventable with appropriate organ support. There is limited data about the type of organ failure leading to death or near-fatal episodes resulting in permanent neurological disability. To assist clinicians facing anaphylaxis in diverse clinical settings, we aimed to quantify the frequency of organ failure type contributing to death or neurological disability from anaphylaxis according to allergen trigger.

Systematic review of published peer-reviewed literature.

Three databases were searched to January 2025: MEDLINE from 1946, Embase from 1947 and Web of Science from 1900.

Studies were eligible if they contained data about the type of clinical deterioration during anaphylaxis resulting in death or permanent neurological disability. No language restriction was implemented. Exclusion criteria were: hydatid anaphylaxis; five or more stings from an insect; death from acute atheromatous myocardial infarction and where anaphylaxis was only a differential diagnosis.

We extracted information using pre-specified criteria to determine the primary organ failure involved: either upper airway obstruction, lower respiratory obstruction (bronchospasm) or cardiovascular failure. Baseline demographics including age and asthma status were collected along with the allergen trigger, time course and treatment. We reported frequencies according to allergen trigger for case reports and a narrative analysis of case series weighted by risk of bias assessment.

277 case studies and 14 case series were identified reporting 896 deaths and 28 disabilities. There were no other study types. Separate case series and case report analyses produced similar findings despite varying quality of published clinical data. Respiratory failure was the most common primary organ failure in case reports (73.4%), whereas primary cardiovascular failure was reported in 26.6% of case reports. Primary organ failure type differed in frequency by allergen trigger and was primarily caused by: respiratory failure when food was the allergen trigger (95%); respiratory failure in 65% of cases of drug allergen triggers; cardiovascular failure in 65% venom allergen triggers.

In this review, respiratory failure (primarily bronchospasm) is the most common primary physiological event leading to decompensation in fatal anaphylaxis, particularly for food and drug allergen deaths. Emphasising the significance of respiratory involvement, particularly from bronchospasm, in both patient and clinician facing anaphylaxis treatment guidelines may help further reduce the risk of fatalities. Prospective anaphylaxis management registries or whole population data are needed to better capture primary organ failure present in fatal anaphylaxis to validate this finding.

CRD42023434206.

Systemic sclerosis (SSc) is a rare autoimmune disease characterised by skin and organ fibrosis, vasculopathy and immune dysregulation. Given the disease heterogeneity and severity, accurate prognostic and predictive markers are needed. Blood immunophenotyping by flow or mass cytometry offers a promising non-invasive approach to identify immune signatures associated with disease subtypes, complications (eg, interstitial lung disease, scleroderma renal crisis, digital ulcers) and treatment responses. However, findings remain inconsistent and lack clinical standardisation. This systematic review aims to identify cytometry-based blood immune markers associated with clinical outcomes in SSc.

A comprehensive search will be conducted on three databases: PubMed, Web of Science and Cochrane Library, from their inception to the date of the final search (21 December 2025). Data will be extracted and analysed using a predefined charting form. Studies published in English or French reporting the use of flow or mass cytometry for peripheral blood cells phenotyping in adults with SSc will be included. Comparators will include healthy controls, other autoimmune diseases, disease severity groups and treatment response subgroups. The primary outcome will be the association with the diffuse cutaneous subtype, while secondary outcomes will include overall survival and disease-specific mortality, organ involvement, progression of the disease and treatment response.

Ethical approval is not required as this review is an analysis of published scientific literature and does not involve patients. The results of this systematic literature review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.

CRD420250644594.

Approximately 6%–10% of adults carry food allergy labels. Many such labels are unverified and may be incorrect, contributing to delays in appropriate care, significant dietary restriction, anxiety and unnecessary use of emergency medications. Oral food challenges (OFCs) are the gold standard for confirming or excluding food allergy, but the current model of clinic-based challenges often has long wait times and logistical barriers. This study aims to investigate the feasibility and safety of home-based OFCs compared with standard in-clinic challenges in adults with negative skin-prick testing.

Food Challenge at HOme or in Medical Practice is a pilot multicentre randomised controlled trial enrolling 120 adults with reported food allergy labels and negative skin prick testing to the implicated food. Participants will be randomised 1:1 to undergo an OFC either at home or in-clinic. The study is designed to generate feasibility and preliminary safety data for home-based OFC, measured by the proportion of participants experiencing immune-mediated adverse events (AEs), compared with clinic-based OFC. Feasibility metrics (screening to recruitment ratio, protocol completion), non-immune AEs, protocol adherence and quality of life assessed using the Food Allergy Quality of Life Questionnaire-12 at baseline prior to OFC and 6 months post OFC will also be collected. Statistical analysis will include descriptive statistics, with comparisons between arms using risk differences and relative risks with 95% CIs.

The trial has received ethics approval from the Austin Health Human Research Ethics Committee (HREC/111750/Austin-2024). Findings will be disseminated through peer-reviewed publications and scientific meetings. Data will be presented in aggregated, de-identified form.

NCT06916819.

To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia.

Adaptive multiarm, multistage, randomised, open-label trial (three arm, two stage).

Five hospitals in England between October 2020 and September 2022.

Hospitalised patients (≥18 years) with COVID-19 pneumonia defined by a modified WHO COVID-19 severity grade of 3 or 4.

Participants were randomly assigned 1:1:1 to receive RUX (10 mg two times per day for 7 days then 5 mg two times per day for 7 days), FOS (150 mg two times per day for 7 days then 100 mg two times per day for 7 days) or SOC.

Primary outcome was development of severe COVID-19 pneumonia (modified WHO severity grade≥5) within 14 days of randomisation. Secondary outcomes included mortality, invasive and non-invasive ventilation, venous thromboembolism, duration of hospital stay, readmissions, inflammatory markers and serious adverse events (SAEs).

At stage 1, 181 patients were randomised, with 4 assessed as ineligible post randomisation. FOS was stopped early for futility with 16 participants (27.6%, n=58) developing severe COVID-19 pneumonia compared with 15 (25.0%, n=60) in the SOC arm (adjusted odds ratio (aOR) compared with SOC: 1.12; 95% CI 0.49 to 2.58; p=0.608). RUX progressed to stage 2 but the trial was stopped early due to slow recruitment. At the final analysis, 10 participants (16.1%, n=62) developed severe COVID-19 pneumonia in the RUX arm compared with 15 (24.6%, n=61) in the SOC arm (aOR: 0.63; 95% CI 0.25 to 1.57; p=0.161). Four (7.4%) participants in the FOS arm, none in the RUX arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported SAE and were numerically higher in the FOS (10, 17.2%) and RUX (10, 16.1%) arms compared with SOC (7, 11.5%). Two unexpected serious adverse reactions occurred in the RUX arm only.

We found no evidence that FOS was superior to SOC for the treatment of COVID-19 pneumonia in patients requiring hospital admission. Due to early stopping, the trial was underpowered to establish RUX’s effect in this population. Further study is needed.

NCT04581954; EUDRA-CT: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001750-22/GB.

To assess the effects of behaviourally informed short message service (SMS) reminders on demand for human papillomavirus (HPV) immunisation.

Individually randomised, five-group, controlled parallel trial.

A country-wide trial in Georgia.

55 176 girls aged 10–12, the entire population of unvaccinated girls of this age in the country, for whom there existed caregiver contact details.

Girls were randomised into five arms (four with n=11 035, with one n=11 036). Caregivers of the girls in four of the arms (treatment groups) were sent different versions of an SMS reminder (SMSR), reminding them that the girl was due to receive the HPV vaccine. The control group was sent no SMSR.

The primary outcome was a girl’s HPV vaccination status at the end of the trial.

Girls and their caregivers were blinded to group assignment.

The number of participants analysed in the four treatment groups was 10,784, 10,802, 10,794 and 10,820, with 10 828 analysed in the control group.

Each of the SMSRs was more effective than the control (no reminder) in encouraging HPV vaccination. Girls whose caregiver(s) were sent version 3 had 65% greater odds of receiving the vaccine relative to the control group (OR=1.65; 95% CI 1.38 to 1.97). Among girls whose caregivers received version 1, version 2 and version 4 of the SMS, the odds of receiving the HPV vaccine were respectively 42% (OR=1.42; 95% CI 1.18 to 1.70), 34% (OR=1.34; 95% CI 1.12 to 1.61) and 35% (OR=1.35; 95% CI 1.13 to 1.62) higher compared with the girls in the control arm.

We find a positive and statistically significant effect for each version of the SMSR, relative to the control condition.

NCT05536674.

This study investigated the perceived clinicians’ roles in penicillin allergy assessment among medical staff in tertiary hospitals in China.

This was a multicentre cross-sectional survey.

The study was conducted at 89 tertiary hospitals in eastern and western China from March to May 2024.

A survey was conducted involving 8493 medical staff from tertiary hospitals in eastern and western China using multistage sampling.

A self-designed questionnaire was used to assess evaluation status of penicillin allergy assessment, including allergy history assessment and recording, skin test result evaluation during hospitalisation, allergic reaction recording at discharge and awareness of allergy assessment teams.

Among 8493 healthcare professionals (doctors 40.0%, nurses 56.3%, pharmacists 3.7%), significant gaps existed in penicillin allergy documentation: while 92.0% acknowledged the need to document specific drug names, only 66.2% practised this (nurses 62.2% vs pharmacists 82.0%, p

Currently, the assessment and recording methods for antimicrobial allergies by the medical staff of tertiary hospitals in China are not sufficiently accurate. Nurses play a key role in the assessment of antimicrobial allergies. Thus, medical staff, especially nurses, should receive more vigorous training, and structured assessment tools for antimicrobial allergies based on clinical decision support systems should be devised for them. Our findings also reiterate the need to establish penicillin allergy assessment teams at the hospital level.

The predisposition to food allergy development and the induction of allergen-specific immune responses appears to be initiated early in infancy. Early exposure to food allergens, such as peanut and cashew nut, via human milk is likely important in initiating oral tolerance and reducing risk of food allergy development. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a high peanut and cashew nut maternal diet during lactation.

This is a multisite, parallel, two-arm (1:1 allocation), single-blinded (outcome assessors, statistical analyst and investigators), randomised controlled trial. Target sample size is 4412 participants (2206 per group). Women (aged 18–50 years) with a singleton pregnancy, who are planning to breastfeed and do not have peanut and/or cashew nut allergies are eligible to participate. After obtaining written informed consent, participants are randomised to either a high peanut and cashew nut diet (at least 60 peanuts and 40 cashew nuts per week) or a low peanut and cashew nut diet (no more than 20 peanuts and 12 cashew nuts per week). Participants are asked to follow their allocated diet from birth to 6 months postnatal. Individual lactation consultant advice and support is provided as required. The study’s primary outcome is food challenge proven IgE-mediated peanut and/or cashew nut allergy during infancy (0–18 months). Key secondary outcomes include infant sensitisation to peanut and/or cashew nut. Analyses will be performed on an intention-to-treat basis according to a prespecified statistical analysis plan.

Ethical approval has been granted from the Western Australian Child and Adolescent Health Service Human Research Ethics Committee (approval number RGS0000006685). Trial results will be presented at scientific conferences and published in peer-reviewed journals.

Australian New Zealand Clinical Trials Registry (ACTRN ACTRN12624000134527)

Ebola virus disease remains a significant public health concern. For protection from Ebola virus, the main target populations are epidemiologically identified and often include healthcare workers and refugees. These target populations are also routinely offered vaccines for other vaccine-preventable diseases. However, concomitant use of rVSVG-ZEBOV-GP with other vaccines is not recommended, given the absence of data regarding its reactogenicity and antigen-specific immunogenicity profile when co-administered. The EbolaCov trial aims to inform whether rVSVG-ZEBOV-GP can be administered concurrent to a Pfizer–BioNTech COVID-19 booster dose without an unacceptable increase in reactogenicity and/or loss of humoral immunogenicity to Ebola vaccine antigen.

This is a single-centre, randomised, single-blinded, vaccine safety and immunogenicity study in healthy adults living in Rwanda. Seventy-two participants will be randomised in a 1:1 ratio to two study groups, the first receiving rVSVG-ZEBOV-GP with a placebo, the second group receiving rVSVG-ZEBOV-GP concurrently with a Pfizer–BioNTech COVID-19 booster dose. The primary outcome measures are quantitative serum anti-glycoprotein (GP) antibody responses, as measured by ELISA, 28 days after vaccination, and frequency and severity of adverse events in the 7 days following vaccination. Secondary outcome measures include day 28 and day 180 serum anti-GP and serum SARS-CoV-2 anti-spike protein-specific geometric mean antibody titres.

This trial was approved by the Rwanda National Ethics Committee (reference 442/2024) and the University of Birmingham (reference ERN_2661-Jun2024). All participants were required to provide written informed consent in accordance with good clinical practice. Dissemination of results will be through conference presentations and peer-reviewed publications.

Pan African Clinical Trials Registry (PACTR202407764378004) and ClinicalTrials.gov (NCT06587503)

Autoimmune disease can greatly affect pregnancy outcomes, leading to increased health risks for both mothers and fetuses. Vitiligo is a common chronic skin condition characterised by the loss of pigment. However, there is controversy regarding adverse pregnancy outcomes (APOs) associated with this condition. Our scoping review aims to explore and summarise the existing literature on pregnancy outcomes in patients with vitiligo.

This scoping review will follow the five-stage methodological framework introduced by Arksey and O’Malley. This stages approach encompasses the following stages: (a) identifying the research questions, (b) identifying relevant research studies, (c) selecting studies, (d) extracting and charting the data and (e) summarising, analysing and reporting the results. We will search two databases, PubMed and Scopus, for published literature up to January 2025 using keywords related to pregnancy outcomes and vitiligo. All retrieved articles will be organised using EndNote software. Two trained reviewers will complete title and abstract screening, full-text screening and data charting. The data will be presented using different strategies, including tables and graphs, to map pregnancy outcomes in patients with vitiligo.

The scoping review will not involve direct contact with humans or patients; therefore, ethical approval is not required for this protocol. The data analysis will focus on exploring APOs in patients with vitiligo. The results of this study will be published in peer-reviewed journals.

To develop a behavioural intervention package to support non-allergist healthcare workers (HCWs) to remove incorrect penA records from medical and surgical adult inpatients. This paper describes the development of the penicillin allergy de-labelling (PADL) intervention and the implementation intervention that will support non-allergist-delivered PADL.

We combined evidence-based, theory-based and person-based approaches. Qualitative research with healthcare professionals and patients explored barriers and enablers to implementation of the proposed PADL pathway. Key intervention design objectives and the key features of the implementation intervention required to achieve each objective were then developed and captured as guiding principles. We produced a logic model, integrating the theoretical domains framework to identify the behavioural influences on PADL and the behaviour change wheel to show how the implementation intervention is hypothesised to address the target behaviours. The implementation intervention package was then reviewed by stakeholders and topic experts for further refinement and optimisation. Finally, we outline how the implementation intervention will be evaluated.

Single-centre District General Hospital in the SW England servicing a rural community of 575 000 people without local allergy services.

HCWs reported PADL needed to be structured, standardised, evidence based and supported by hospital approved guidelines with easy to access patient information leaflets, supported by a sustained programme of education and training with named PADL leaders and visible PADL champions. Patients wanted a good explanation of the benefits and risks of testing and the benefits of having their ‘penA’ record removed. The identified HCW target behaviours were: taking a penA allergy focused history and to risk assess the patient’s penA history; to then either de-label the patient on history alone (direct de-label; DDL) or prescribe a direct oral challenge (DOC) dose; to perform baseline and post-test observations and counsel the patient on the risks of penA records and on the risks and the benefits of PADL. We identified barriers to target behaviours that we considered both important and modifiable, which included: lack of confidence in taking a penA focused history, PADL not viewed as a priority, low confidence with differentiating low-risk and high-risk penA histories, concerns about the safety of DOC, a requirement for senior support for nurses to deliver the observations and senior support for the other HCWs to deliver PADL, access to an expert for advice when required, a lack of PADL champions to promote PADL, and PADL not being supported by the organisation. The identified patient target behaviours were acceptance of the opportunity to be de-labelled via either DDL or DOC and willingness to take penicillin when prescribed. We developed intervention components to target the HCW and patient target behaviours which included: Education, expert advice made available from Infection specialists, a named PADL champion, hospital endorsed PADL guideline with necessary tools to enable PADL and patient information leaflets. The implementation intervention was further optimised through workshops with PADL researchers and stakeholders. The Consolidated Framework for Implementation Research outcome addendum was used to define both implementation intervention and PADL intervention outcomes.

We have developed a theory-based and stakeholder-developed implementation intervention to support inpatient PADL delivered by a multiprofession workforce. The intervention will be tested in a single hospital and scalability explored.

Systemic lupus erythematosus (SLE) is a chronic and complex multisystem autoimmune disease with high mortality. Telitacicept is a new strategy for the treatment of SLE, inhibiting the maturity, proliferation and differentiation of B cells, and thus, reduces disease activity. However, the effectiveness and safety of telitacicept in patients with SLE are not yet established.

Five English databases (Pubmed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature) and four Chinese databases (China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database and Sinomed) will be searched from database inception to 1 June 2025. Two investigators will independently conduct study selection, data extraction and quality assessment. Outcomes include disease activity, incidence of flares, organ damage, several immune-related laboratory parameters and adverse events. Risk ratio with 95% CI and mean difference or standardised mean difference will be used as measures of effect sizes, in order to pool the data using either a random-effect model or fixed-effect model according to the heterogeneity of studies. Subgroup analysis and sensitivity analysis will be performed to explore the source of heterogeneity and evaluate the robustness of the results. We will use the Risk of Bias 2 tool and Risk of Bias In Non-Randomized Studies of Interventions tools to assess the quality of the included studies, and use the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system to assess the certainty of evidence.

No ethical approval is required since this review is based on previously published studies. The findings of this study will be presented at international conferences or published in a peer-reviewed journal.

CRD42024558180.

The prevalence of food allergies, particularly IgE-mediated allergies, is rising in developed countries, with cashew nut allergy emerging as a significant public health concern due to its potential for severe anaphylaxis and frequent association with atopic disorders. Cashew nuts are among the most common allergens in Europe and Australia, often involving cosensitisation with pistachios, hazelnuts and other allergens. Diagnosis relies on clinical history, measurement of specific IgE (sIgE) levels, skin prick tests (SPT) and oral food challenges (OFCs). Current management strategies focus on allergen avoidance and emergency interventions, whereas oral immunotherapy (OIT) represents a promising approach to desensitisation. Recent studies, including the NUT CRACKER trial, have reported high desensitisation rates with cashew OIT, although these are associated with a risk of adverse events. This study introduces a novel randomised controlled trial aimed at evaluating the efficacy and safety of cashew immunotherapy in children.

This randomised, open-label, parallel-group trial, with a 2:1 allocation ratio, will be conducted at the Department of Paediatric Pneumology and Allergology, Medical University of Warsaw, Poland. Thirty-nine children, aged 4–17 years, with confirmed IgE-mediated cashew allergy via open OFC will be enrolled. Participants in the experimental group will undergo OIT, which involves gradually increasing doses of cashew protein up to a maintenance dose of 1200 mg. The duration of OIT will range from 12 to 60 weeks, depending on individual baseline tolerance. The control group will receive standard management, including strict cashew avoidance and emergency response strategies to accidental exposure, for 1 year.

The primary endpoint is to determine the proportion of participants tolerating a 4043 mg dose of cashew protein at the study’s end in the OIT group compared with the control group. Secondary outcomes include evaluating the safety profile of OIT, assessing changes in laboratory markers such as sIgE and IgG4 levels for cashew and the major cashew allergen Ana o 3, analysing basophil activation test responses and measuring changes in SPT wheal diameter at baseline and study completion.

The study has been approved by the Ethics Committee of the Medical University of Warsaw (approval number: KB/267/2023). Study findings will be published in peer-reviewed journals and presented at international conferences.

NCT06328504.