Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia

Summary

The main questions this study aims to answer are: * Does using probiotic nasal spray (LiveSpo Navax containing Bacillus subtilis and Bacillus clausii, 1x10\^9 CFU/mL), with or without oral probiotics (LiveSpo Pregmom containing Bacillus subtilis, Bacillus clausii, and Bacillus coagulans, 3x10\^9 CFU/5 mL), help children recover better from pneumonia when added to standard medical treatment? * Does using these adjunctive probiotics support reduce the recurrence of respiratory and gastrointestinal symptoms after hospital discharge? Researchers will compare three groups of children to see whether probiotic nasal spray alone or probiotic nasal spray combined with oral probiotics works better than placebo. All participants will receive standard medical treatment for pneumonia. In addition, they will be randomly assigned to one of three study groups to receive adjunctive probiotic support in 2 months: * Control group: receives a saline nasal-throat spray (0.9% NaCl) and oral placebo liquid (RO water). * Nasal probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray and oral placebo liquid (RO water). * Nasal plus oral probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray plus LiveSpo® Preg-Mom oral probiotic suspension. Participants will: * Use a nasal-throat spray three times a day. * Take an oral liquid twice daily. * Start using the study products during their hospital stay and continue for 8 weeks (2 months) from admission. * Be followed by the study team during hospitalization and at Day 30 and Day 60 after admission. The probiotic and placebo products look, smell, and taste the same so that neither the parents nor the study staff know which product each child receives.

Timeline

Start

2026-01-26

Primary completion

2026-12-30

Completion

2027-12-30

Publications

• Background Dao BN, Le HDT, Ta TB, et al. Relationship between serum TNF-α, IL-6, and IL-10 levels and disease severity, and changes in the cytokines after treatment in patients with bacterial community-acquired pneumonia. Pneumon. 2023; doi.org/10.18332/pne/170181
• Background Zhang Z, Dou H, Tu P, Shi D, Wei R, Wan R, Jia C, Ning L, Wang D, Li J, Dong Y, Xin D, Xu B. Serum cytokine profiling reveals different immune response patterns during general and severe Mycoplasma pneumoniae pneumonia. Front Immunol. 2022 Dec 22;13:1088725. doi: 10.3389/fimmu.2022.1088725. eCollection 2022.
• Background Ness-Cochinwala M, Totapally BR. A Comprehensive Review of Pediatric Necrotizing Pneumonia. Children (Basel). 2025 Sep 17;12(9):1248. doi: 10.3390/children12091248.
• Background Roh EJ, Shim JY, Chung EH. Epidemiology and surveillance implications of community-acquired pneumonia in children. Clin Exp Pediatr. 2022 Dec;65(12):563-573. doi: 10.3345/cep.2022.00374. Epub 2022 Oct 17.
• Background Turalde-Mapili MWR, Mapili JAL, Turalde CWR, Pagcatipunan MR. The efficacy and safety of nirsevimab for the prevention of RSV infection among infants: A systematic review and meta-analysis. Front Pediatr. 2023 Apr 4;11:1132740. doi: 10.3389/fped.2023.1132740. eCollection 2023.
• Background Han JS, Jang SH, Jeon JS, Lee KB, Kim JK. Epidemiological Shifts in Respiratory Virus Infections Among Older Adults (>/=65 Years) Before and After the COVID-19 Pandemic: An 18-Year Retrospective Study in the Republic of Korea. Microorganisms. 2025 Oct 3;13(10):2301. doi: 10.3390/microorganisms13102301.
• Background Khieu TH, Le DP, Nguyen BT, Ngo BT, Chu HT, Truong DM, Nguyen HM, Nguyen AH, Pham TD, Van Nguyen AT. Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial. Sci Rep. 2025 Jan 27;15(1):3410. doi: 10.1038/s41598-025-87372-2.
• Background Zou Y, Huang F, Sun J, Zheng Y, Dai G, Wang T, Zhu C, Yan Y, Wang R, Chen Z. The role of IFN-gamma/CXCL10 axis in Mycoplasma pneumonia infection. Sci Rep. 2025 Jan 21;15(1):2671. doi: 10.1038/s41598-024-84969-x.
• Background Chen Z, Liu Y, Huang W. Alveolar macrophage modulation via the gut-lung axis in lung diseases. Front Immunol. 2023 Nov 21;14:1279677. doi: 10.3389/fimmu.2023.1279677. eCollection 2023.
• Background Thi Le H, Thi Bich Phung T, Thi Bui H, Thi Hong Le H, Tran DM, Nguyen NH, Phan HT, Tran VD, Vu Pham U, Van Phan N, Thu Do H, Nguyen AH, Pham TD, Thi Van Nguyen A. Nasal-spraying Bacillus spore probiotics for pneumonia in children with respiratory syncytial virus and bacterial co-infections: a randomized clinical trial. Commun Med (Lond). 2025 Aug 7;5(1):336. doi: 10.1038/s43856-025-01029-9.
• Background Tran XD, Hoang VT, Goumballa N, Vu TN, Tran TK, Pham TD, Dao TL, Vu TT, Nguyen DC, Nguyen QT, Marty P, Gautret P. Viral and bacterial microorganisms in Vietnamese children with severe and non-severe pneumonia. Sci Rep. 2024 Jan 2;14(1):120. doi: 10.1038/s41598-023-50657-5.
• Background Tran DM, Tran TT, Phung TTB, Bui HT, Nguyen PTT, Vu TT, Ngo NTP, Nguyen MT, Nguyen AH, Nguyen ATV. Nasal-spraying Bacillus spores as an effective symptomatic treatment for children with acute respiratory syncytial virus infection. Sci Rep. 2022 Jul 20;12(1):12402. doi: 10.1038/s41598-022-16136-z.

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