scholarly journals 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

Author(s):  
Karl-Christian Bergmann ◽  
Anke Graessel ◽  
Jennifer Raab ◽  
Werner Banghard ◽  
Linda Krause ◽  
...  

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).

Author(s):  
Karl-Christian Bergmann ◽  
Jennifer Raab ◽  
Linda Krause ◽  
Sylvia Becker ◽  
Sebastian Kugler ◽  
...  

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).


2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Lubnaa Hossenbaccus ◽  
Sophia Linton ◽  
Jenny Thiele ◽  
Lisa Steacy ◽  
Terry Walker ◽  
...  

Abstract Rationale The Environmental Exposure Unit (EEU), a controlled allergen exposure model of allergic rhinitis (AR), has traditionally utilized seasonal allergens. We sought to clinically validate the use of house dust mite (HDM), a perennial allergen, in the HDM-EEU, a specially designed facility within the larger EEU. Methods Forty-four HDM-allergic and eleven non-allergic participants were screened and deemed eligible for one of two 3-h exposure sessions in the HDM-EEU. Participants were exposed to a modest or higher HDM target, with blood and nasal brushing samples collected before and after allergen exposure. Symptomatic data, including Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Total Rhinoconjunctivitis Symptom Score (TRSS), and Peak Nasal Inspiratory Flow (PNIF) were collected at baseline, every 30 min until 3 h, on an hourly basis for up to 12 h, and at 24 h following the onset of HDM exposure. Results The modest and higher HDM target sessions respectively featured cumulative total particle counts of 156,784 and 266,694 particles (2.5–25 µm), Der f 1 concentrations of 2.67 ng/m3 and 3.80 ng/m3, and Der p 1 concentrations of 2.07 ng/m3 and 6.66 ng/m3. Allergic participants experienced an increase in symptoms, with modest target participants plateauing at 1.5 to 2 h and achieving a mean peak TNSS of 5.74 ± 0.65, mean peak TOSS of 2.47 ± 0.56, and mean peak TRSS of 9.16 ± 1.32. High HDM-target allergics reached a mean peak TNSS of 8.17 ± 0.71, mean peak TOSS of 4.46 ± 0.62, and mean peak TRSS of 14.08 ± 1.30 at 3 h. All allergic participants’ symptoms decreased but remained higher than baseline after exiting the HDM-EEU. Sixteen participants (37.2%) were classified as Early Phase Responders (EPR), eleven (25.6%) as protracted EPR (pEPR), seven (16.3%) as Dual Phase Responders (DPR), and nine (20.9%) as Poor Responders (PR). Allergic participants experienced significant percent PNIF reductions at hours 2 and 3 compared to healthy controls. Non-allergics were asymptomatic during the study period. Conclusions The HDM-EEU is an appropriate model to study HDM-induced AR as it can generate clinically relevant AR symptoms amongst HDM-allergic individuals.


Allergy ◽  
2019 ◽  
Vol 74 (11) ◽  
pp. 2191-2198 ◽  
Author(s):  
Philippe Devillier ◽  
Harald Brüning ◽  
Karl‐Christian Bergmann

2017 ◽  
Vol 131 (11) ◽  
pp. 997-1001 ◽  
Author(s):  
E Sahin ◽  
D Dizdar ◽  
M E Dinc ◽  
A A Cirik

AbstractBackground:Allergic rhinitis is strongly associated with the presence of house dust mites. This study investigated the long-term effects of allergen-specific immunotherapy. Allergen-specific immunotherapy was applied over three years. The study was based on a 10-year follow up of patients with allergic rhinitis.Methods:The study was conducted between 2001 and 2015. Skin prick test results and symptom scores were evaluated before (26 patients) and after 3 years (20 patients) of allergen-specific immunotherapy (using data from a previously published study), and 10 years after allergen-specific immunotherapy had ended (20 of 26 patients).Results:The symptom scores before allergen-specific immunotherapy were significantly higher than those obtained after 3 years of allergen-specific immunotherapy and 10 years after allergen-specific immunotherapy (p < 0.0175). There were no significant differences between the scores obtained at 3 years and 10 years after allergen-specific immunotherapy (p > 0.0175).Conclusion:Subcutaneous immunotherapy is an effective treatment for house dust mite induced allergic rhinitis.


Indoor Air ◽  
2014 ◽  
Vol 25 (3) ◽  
pp. 235-244 ◽  
Author(s):  
I. Bakolis ◽  
J. Heinrich ◽  
J. P. Zock ◽  
D. Norbäck ◽  
C. Svanes ◽  
...  

2017 ◽  
Vol 139 (3) ◽  
pp. 844-854 ◽  
Author(s):  
Sunil K. Ahuja ◽  
Muthu Saravanan Manoharan ◽  
Nathan L. Harper ◽  
Fabio Jimenez ◽  
Benjamin D. Hobson ◽  
...  

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