Abstract
Summary Purpose The long-term effects of targeted micronutrition with the holoBLG lozenge in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients were evaluated at a follow-up visit in an allergen exposure chamber (AEC). Methods Patients who were supplemented for 3‑months with the holoBLG lozenge in a previous study with two controlled HDM-AEC challenges [visits: V1, V3] were recruited for a third AEC challenge (V5) 7–8 months after cessation of supplementation. Symptoms (nose, conjunctival, bronchial, others), well-being, and lung function parameters were recorded exactly as in the previous study. Primary endpoint was change in median Total Nasal Symptom Score (TNSS) at V5 compared to V1. Secondary endpoints included e.g. change in median Total Symptom Score (TSS) and the exploratory analysis of temporal evolution of symptom scores using linear mixed effects models. Results Of the 32 patients included in the original study, 27 could be recruited for the follow-up visit with a third AEC challenge. An improvement of 20% (p = 0.15) in the primary endpoint TNSS [V1: 2.5 (interquartile range [IQR]: 1–4), V5: 2.0 (IQR: 1–3)] was observed; 40% (p = 0.04) improvement was seen for the TSS [V1: 5.0 (IQR: 3–9), V5: 3.0 (IQR: 2–5.5)]. Analysis of temporal evolution of all symptom scores, and the personal well-being revealed sustained, clinically meaningful improvement at V5 compared to V1. No relevant lung function parameter differences were observed. Conclusions Sustained long-term reduction of TNSS (primary endpoint) and sustained long-term improvement of secondary endpoints (temporal evolution of all symptom scores and well-being) were demonstrated 7–8 months after cessation of holoBLG supplementation, indicative of a long-lasting nature of immune resilience induced by holoBLG. Trial registration The study was registered at clinicaltrials.gov (NCT04872868).
Highlights
The concept of targeted micronutrition to correct micronutritional deficiencies in immune cells of allergic patients, the main attribute of mode-of-action of loaded beta-lactoglobulin, has been unravelled only recently [3,4,5,6]
A unique opportunity for allergic patients presents itself, based on correcting micronutritional deficiencies which provide an antigen-unspecific immune-regulatory effect resulting in resilience to immune activation—“immune resilience”—and protection against allergic sensitization and symptoms [2, 3, 16]
Study design and materials In January and February 2021, those 32 house dust mite (HDM) allergic patients with HDM allergic rhinoconjunctivitis (ARC) who participated in the intervention phase (NCT04477382) [2], and underwent two controlled HDM-exposures (V1 and V3) as well as a 3-month course with the holoBLG lozenge, were asked to participate in a follow-up visit
Summary
The concept of targeted micronutrition to correct micronutritional deficiencies in immune cells of allergic patients, the main attribute of mode-of-action of loaded beta-lactoglobulin (holoBLG), has been unravelled only recently [3,4,5,6]. There are multiple studies showing that atopy is associated with iron deficiencies [7,8,9,10,11] and/or vitamin deficiencies [12,13,14,15] These deficiencies turn the immune system into a hyperreactive state, contributing to the atopic state [8, 15]. The concept of classical AIT is desensitization, administering the allergy-eliciting allergen in a repeated fashion in order to induce tolerance and mount a long-lasting effect based on cellular and humoral immunity [17, 18]. A unique opportunity for allergic patients presents itself, based on correcting micronutritional deficiencies which provide an antigen-unspecific immune-regulatory effect resulting in resilience to immune activation—“immune resilience”—and protection against allergic sensitization and symptoms [2, 3, 16]
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