Targeted micronutrition via holo-BLG based on the farm effect in house dust mite allergic rhinoconjunctivitis patients – first evaluation in a standardized allergen exposure chamber

Abstract

Purpose Evaluation of a lozenge for targeted micronutrition (holo-BLG), a new invention based on the farm effect, in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients in a standardized allergen exposure chamber (AEC). Methods Eligible HDM allergic patients were exposed to HDM raw material in an AEC for 120 min before (V1) and after (V3) 3 months of holo-BLG supplementation. Nasal, conjunctival, bronchial and other symptoms were rated by the patients every 10 min and, wellbeing, peak nasal inspiratory flow (PNIF), and lung function parameters every 30 min. Primary endpoint was the change in median Total Nasal Symptom Score (TNSS) at V3 compared to V1 at 120 min of exposure. Secondary endpoints consisted of the exploratory analysis of the temporal evolution of symptom scores using linear mixed effects models. Results A total of 32 patients were included in the analysis. A significant improvement of 60% (p = 0.0034) in the primary endpoint TNSS (V1 2.5 [interquartile range, IQR 1–4], V3 1.0 [IQR 1–3]) was observed. 40% improvement was seen for the Total Symptom Score (V1 5.0 [IQR 3–9], V3 3.0 [IQR 2–4]; [Wilcoxon test: confidence interval 1.5–4.0, p < 0.0003]). The analysis of the temporal evolution of all symptom scores and the personal wellbeing revealed clinically meaningful improvement over time, manifested in a lower symptom increase during the final HDM exposure. No relevant differences were observed for PNIF and lung function parameters. Safety and tolerability were rated as excellent. Conclusions The effect of holo-BLG resulting in immune resilience might help to fight the allergy epidemic on a new front based on targeted micronutrition of immune cells. Trial registration The study was retrospectively registered at clinicaltrials.gov (NCT04477382).

Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients

“…Furthermore, there are patients who are simply not suitable or motivated to receive an AIT course of 3 years. 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].…”

Targeted micronutrition for allergic patients—possible applications of a food for special medical purposes

“…Supplementation with holo-BLG achieved a significant improvement of 60% (p = 0.0034) in the primary endpoint (total nasal symptom score) [20].…”

“…In summary, the available study results [19,20] and the associated immunological effects [11] indicate that supplementation with holo-BLG can lead to immune resilience in patients with allergic rhinitis, whereby this phenomenon is not allergen-specific. The preclinical data could now be supported accordingly by early clinical data.…”

One Health in allergology: A concept that connects humans, animals, plants, and the environment

“…When BLG shuttles ligands into immune cells, it causes immuneresilience, while uptake without ligands evokes a Th2-response in vitro, resulting in allergy in murine models. [17][18][19][20][21][22] Moreover, symptom reduction could be achieved by consumption of loaded BLG in house dust-mite allergic 23 and birch pollen allergic patients. 24 Apart from this being an important immunological observation, following the One Health concept, we must scrutinize its systematic impact for humans and animals.…”

“…It was shown that the loading of BLG with vitamins and iron complexes is decisive: When BLG shuttles ligands into immune cells, it causes immune‐resilience, while uptake without ligands evokes a Th2‐response in vitro , resulting in allergy in murine models. 17 , 18 , 19 , 20 , 21 , 22 Moreover, symptom reduction could be achieved by consumption of loaded BLG in house dust‐mite allergic 23 and birch pollen allergic patients. 24…”