Randomized, Double-Blind, Placebo-Controlled Trial of a Throat Spray with Selected Lactobacilli in COVID-19 Outpatients

Boeck, Ilke De; Cauwenberghs, Eline; Spacova, Irina; Gehrmann, Thies; Eilers, Tom; Delanghe, Lize; Wittouck, Stijn; Bron, Peter A.; Henkens, Tim; Gamgami, Imane; Simons, Alix; Claes, Ingmar; Mariën, Joachim; Ariën, Kevin K.; Bakokimi, Diana; Loens, Katherine; Jacobs, Kevin; Ieven, Margareta; Bruijning-Verhagen, Patricia C J L; Delputte, Peter; Coenen, Samuel; Verhoeven, Veronique; Lebeer, Sarah

doi:10.1128/spectrum.01682-22

Cited by 21 publications

(23 citation statements)

References 49 publications

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“…We also found that individuals with Bacillus species in their upper respiratory tract may have a lower likelihood of developing severe COVID-19 when compared with mild cases. This finding is similar to the outcome of a prior study that demonstrated that treatment with lactobacilli had the potential to lower the viral load of SARs-COV-2 in the upper respiratory tract without necessarily resolving the symptoms of COVID-19 [17]. The lower likelihood of severe COVID-19 compared to mild COVID-19 when Bacillus is present may also be related to the reduction or improvement of the symptoms of SARs-COV-2 infection by the Bacillus species.…”

Section: Discussionsupporting

confidence: 85%

“…Bacillus subtilis possesses the probiotic potential to increase mucosal and tonsillar immunity against respiratory diseases through the formation of immune cells in the nasal cavity and tonsil [15]. Like bacilli intranasal sprays, lactobacilli-containing throat sprays have also been demonstrated to considerably lessen the acute symptoms of COVID-19 as well as the load of the virus in the nasopharynx [17]. However, there are currently no studies showing the effect of nasal carriage of Bacillus species on the susceptibility to SARS-CoV-2 infection and severity.…”

Section: Introductionmentioning

confidence: 99%

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Effect of nasal carriage ofBacillusspecies on COVID-19 severity: A cross-sectional study

Fowora¹,

Aiyedogbon²,

Omolopo³

et al. 2023

Preprint

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Intranasal sprays containing Bacillus species are being researched for treating viral respiratory tract infections. The aim of this study was to assess the relationship between the nasal carriage ofBacillusand COVID-19 severity. This was a cross-sectional study that collected nasopharyngeal samples from adults 18 years and above visiting two COVID-19 testing centers in Lagos, Nigeria between September 2020 and September 2021. Bacillus species were cultured from the respiratory samples and confirmed using molecular methods. The dependent variable was COVID-19 status classified as negative, asymptomatic, mild, or severe. The independent variable was the nasal carriage of Bacillus species. Multinomial regression analysis was done to determine the association between nasal carriage of Bacillus and COVID-19 severity after adjusting for age, sex, and co-morbidity status. About 388 participants were included in the study with a mean (standard deviation) age of 40.05 (13.563) years. The majority (61.1%) of the participants were male, 100 (25.8%) had severe COVID-19, 130 (33.5%) had pre-existing comorbidity, and 76 (19.6%) had Bacillus cultured from their nasopharyngeal specimen. Bacillus species presence was significantly associated with higher odds of severe COVID-19 compared to having a negative COVID-19 status. However, the presence of Bacillus species was significantly associated with lower odds of severe COVID-19 compared to having a mild COVID-19 status. The study suggests that nasal carriage of Bacillus species may substantially impact the clinical course of COVID-19. This study supports the exploration ofBacillusspecies in the prevention and management of viral respiratory tract infections.

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Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Effect of nasal carriage ofBacillusspecies on COVID-19 severity: A cross-sectional study

Fowora¹,

Aiyedogbon²,

Omolopo³

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…The safety and well‐tolerability of probiotics have been reported by previous studies 18,33,37–40 . A pilot trial conducted by Cabrera et al revealed that the multi‐strain probiotic supplement containing Bifidobacteria , Lactobacilli , and Streptococcus species was safe and well‐tolerated regarding the absence of adverse side effects and high adherence of patients to consume the mentioned product 18 .…”

Section: Discussionmentioning

confidence: 75%

The effect of synbiotic adjunct therapy on clinical and paraclinical outcomes in hospitalized COVID‐19 patients: A randomized placebo‐controlled trial

Vaezi

Ravanshad

Rad

et al. 2023

Journal of Medical Virology

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Therapeutic approaches with immune-modulatory effects such as probiotics and prebiotics adjuvant therapy may be essential to combat against COVID-19 pandemic. The present trial aimed to reveal the efficacy of synbiotic supplementation on clinical and paraclinical outcomes of hospitalized COVID-19 patients. The current randomized placebo-controlled trial enrolled 78 hospitalized patients with confirmed COVID-19 infection. Participants were randomly allocated to intervention and control groups that received synbiotic or placebo capsules twice daily for 2 weeks, respectively. The synbiotic capsule contains multi-strain probiotics such as

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“…Temporary throat colonization by the administered lactobacilli was demonstrated. The spray might be a stepping stone for prevention and treatment of viral respiratory tract infections with locally applied beneficial bacteria, and first positive results have already been obtained upon its evaluation in COVID‐19 primary care patients (De Boeck et al, 2022 ).…”

Section: Discussionmentioning

confidence: 99%

Development of a live biotherapeutic throat spray with lactobacilli targeting respiratory viral infections

Spacova

Boeck

Cauwenberghs

et al. 2022

Microbial Biotechnology

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Respiratory viruses such as influenza viruses, respiratory syncytial virus (RSV), and coronaviruses initiate infection at the mucosal surfaces of the upper respiratory tract (URT), where the resident respiratory microbiome has an important gatekeeper function. In contrast to gut-targeting administration of beneficial bacteria against respiratory viral disease, topical URT administration of probiotics is currently underexplored, especially for the prevention and/or treatment of viral infections. Here, we report the formulation of a throat spray with live lactobacilli exhibiting several in vitro mechanisms of action against respiratory viral infections, including induction of interferon regulatory pathways and direct inhibition of respiratory viruses. Rational selection of Lactobacillaceae strains was based on previously documented beneficial properties, up-scaling and industrial production characteristics, clinical safety parameters, and potential antiviral and immunostimulatory efficacy in the URT demonstrated in this study. Using a three-step selection strategy, three strains were selected and further tested in vitro antiviral assays and in formulations: Lacticaseibacillus casei AMBR2 as a promising endogenous candidate URT probiotic with previously reported barrier-enhancing and anti-pathogenic properties and the two well-studied model strains Lacticaseibacillus rhamnosus GG and Lactiplantibacillus plantarum WCFS1 that display immunomodulatory capacities. The three strains and their combination significantly reduced the cytopathogenic effects of RSV, influenza A/H1N1 and B viruses, and HCoV-229E coronavirus in co-culture models with bacteria, virus, and host cells. Subsequently, these strains were formulated in a throat spray and human monocytes were employed to confirm the formulation process did not reduce the interferon regulatory pathway-inducing capacity. Administration of the throat spray in healthy volunteers revealed that the lactobacilli were capable of temporary colonization of the throat in a metabolically active form. Thus, the developed spray with live lactobacilli will be further explored in the clinic as a potential broad-acting live biotherapeutic strategy against respiratory viral diseases.

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Randomized, Double-Blind, Placebo-Controlled Trial of a Throat Spray with Selected Lactobacilli in COVID-19 Outpatients

Cited by 21 publications

References 49 publications

Effect of nasal carriage ofBacillusspecies on COVID-19 severity: A cross-sectional study

Effect of nasal carriage ofBacillusspecies on COVID-19 severity: A cross-sectional study

The effect of synbiotic adjunct therapy on clinical and paraclinical outcomes in hospitalized COVID‐19 patients: A randomized placebo‐controlled trial

Development of a live biotherapeutic throat spray with lactobacilli targeting respiratory viral infections

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