Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial
Abstract Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of t...
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Nature Portfolio
2025-01-01
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| Online Access: | https://doi.org/10.1038/s41598-025-87372-2 |
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| author | Thanh Huu Khieu Dung Phuong Le Binh Thanh Nguyen Binh Thanh Ngo Hong Thi Chu Duc Minh Truong Hung Minh Nguyen Anh Hoa Nguyen Tung Dinh Pham Anh Thi Van Nguyen |
| author_facet | Thanh Huu Khieu Dung Phuong Le Binh Thanh Nguyen Binh Thanh Ngo Hong Thi Chu Duc Minh Truong Hung Minh Nguyen Anh Hoa Nguyen Tung Dinh Pham Anh Thi Van Nguyen |
| author_sort | Thanh Huu Khieu |
| collection | DOAJ |
| description | Abstract Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of the nasal-spraying probiotics (LiveSpo Navax containing 5 billion Bacillus subtilis and B. clausii spores/5 mL) as a supportive treatment for dual ARS and AOM with otorrhea in a randomized, single-blind, controlled clinical trial. Eighty-two patients (41 per group), aged 1 month to 12 years, received standard care along with nasal spraying of either physiological saline (Control group) or LiveSpo Navax (Navax group), administered three times daily over a 7-day follow-up period. A total of sixty-one patients (30–31 per group) completed the trial. The Navax group experienced 68.00% and 96.77% reductions in nasal congestion (by day 3) and rhinorrhea (by day 7), respectively, which were 2.04 and 1.94-fold higher than the Control group, with odds ratios (OR) of 4.31 and 30.00 (p < 0.05). Endoscopic results indicated 8% and 11% higher reductions in nasal mucopurulent discharge and tympanic membrane hyperemia in the Navax group compared to the Control group. By day 3, compared to day 0, the Navax group exhibited > 1200-fold reduction in Streptococcus pneumoniae and ≥ 4-fold reduction in Haemophilus influenzae concentrations (p < 0.05) in both nasopharyngeal and middle ear fluid samples, whereas the Control group showed no significant reductions. Navax treatment reduced IL-6 by 1.35- to 1.74-fold and TNF-α by 1.17- to 1.45-fold, more effectively than the Control group (p < 0.05). These results suggest that nasal-spray Bacillus spore probiotics, with their ability to reduce bacterial load and modulate immune responses, provide a cost-effective and safe solution for alleviating symptoms of both ARS and AOM in children. Trial registration: ClinicalTrials.gov, Identifier NCT05804123 on April 7, 2023. |
| format | Article |
| id | doaj-art-1c386b1ca777467f903bdbdfc213804f |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-1c386b1ca777467f903bdbdfc213804f2025-02-02T12:22:33ZengNature PortfolioScientific Reports2045-23222025-01-0115111310.1038/s41598-025-87372-2Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trialThanh Huu Khieu0Dung Phuong Le1Binh Thanh Nguyen2Binh Thanh Ngo3Hong Thi Chu4Duc Minh Truong5Hung Minh Nguyen6Anh Hoa Nguyen7Tung Dinh Pham8Anh Thi Van Nguyen9Thai Binh University of Medicine and PharmacySpobiotic Research Center, ANABIO R&D Ltd. CompanyThai Binh University of Medicine and PharmacyThai Binh University of Medicine and PharmacyThai Binh University of Medicine and PharmacyThai Binh University of Medicine and PharmacyThai Binh Pediatric HospitalSpobiotic Research Center, ANABIO R&D Ltd. CompanyFaculty of Mathematics - Mechanics - Informatics, VNU University of Science, Vietnam National University_HanoiSpobiotic Research Center, ANABIO R&D Ltd. CompanyAbstract Acute rhinosinusitis (ARS) in children may be accompanied by acute otitis media (AOM) which is often associated with bacterial co-infections. These conditions are among the primary reasons that children visit hospitals and require antibiotic treatment. This study evaluated the efficacy of the nasal-spraying probiotics (LiveSpo Navax containing 5 billion Bacillus subtilis and B. clausii spores/5 mL) as a supportive treatment for dual ARS and AOM with otorrhea in a randomized, single-blind, controlled clinical trial. Eighty-two patients (41 per group), aged 1 month to 12 years, received standard care along with nasal spraying of either physiological saline (Control group) or LiveSpo Navax (Navax group), administered three times daily over a 7-day follow-up period. A total of sixty-one patients (30–31 per group) completed the trial. The Navax group experienced 68.00% and 96.77% reductions in nasal congestion (by day 3) and rhinorrhea (by day 7), respectively, which were 2.04 and 1.94-fold higher than the Control group, with odds ratios (OR) of 4.31 and 30.00 (p < 0.05). Endoscopic results indicated 8% and 11% higher reductions in nasal mucopurulent discharge and tympanic membrane hyperemia in the Navax group compared to the Control group. By day 3, compared to day 0, the Navax group exhibited > 1200-fold reduction in Streptococcus pneumoniae and ≥ 4-fold reduction in Haemophilus influenzae concentrations (p < 0.05) in both nasopharyngeal and middle ear fluid samples, whereas the Control group showed no significant reductions. Navax treatment reduced IL-6 by 1.35- to 1.74-fold and TNF-α by 1.17- to 1.45-fold, more effectively than the Control group (p < 0.05). These results suggest that nasal-spray Bacillus spore probiotics, with their ability to reduce bacterial load and modulate immune responses, provide a cost-effective and safe solution for alleviating symptoms of both ARS and AOM in children. Trial registration: ClinicalTrials.gov, Identifier NCT05804123 on April 7, 2023.https://doi.org/10.1038/s41598-025-87372-2AcuteRhinosinusitisOtitis mediaNasal-spraying Bacillus sporesBacterial co-infectionCytokine |
| spellingShingle | Thanh Huu Khieu Dung Phuong Le Binh Thanh Nguyen Binh Thanh Ngo Hong Thi Chu Duc Minh Truong Hung Minh Nguyen Anh Hoa Nguyen Tung Dinh Pham Anh Thi Van Nguyen Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial Scientific Reports Acute Rhinosinusitis Otitis media Nasal-spraying Bacillus spores Bacterial co-infection Cytokine |
| title | Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial |
| title_full | Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial |
| title_fullStr | Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial |
| title_full_unstemmed | Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial |
| title_short | Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial |
| title_sort | alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal spraying bacillus probiotics a randomized controlled trial |
| topic | Acute Rhinosinusitis Otitis media Nasal-spraying Bacillus spores Bacterial co-infection Cytokine |
| url | https://doi.org/10.1038/s41598-025-87372-2 |
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