Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infections

Summary

Respiratory syncytial virus (RSV) infection and bacterial co-infection are the most common causes of pneumonia. Currently, there is no vaccine available for RSV prevention, and the use of the antiviral medication ribavirin is not widely recommended for children. Therefore, the primary treatment approach follows the general protocol for pneumonia, and oxygen therapy is recommended for all cases of pneumonia with respiratory failure. However, in children, the treatment of RSV and bacterial pneumonia remains supportive to prevent bacterial co-infection and respiratory failure. Probiotics have emerged as promising and safe options for supporting the treatment of acute respiratory tract infections (ARTIs) and reducing dependence on antibiotics in recent years. In this study, investigators propose that the direct administration of probiotics through a nasal spray can offer rapid and effective symptomatic treatment for children with pneumonia who require oxygen therapy due to RSV and bacterial co-infections. The aim of the study is to evaluate the effectiveness of nasal-spraying probiotics containing spores of two bacterial strains, Bacillus subtilis and Bacillus clausii (LiveSpo Navax), in preventing and supporting the treatment of severe pneumonia in children (who require oxygen therapy) caused by RSV infection and bacterial co-infection. Study population: The sample size was 100, and the study was conducted at the Vietnam National Children's Hospital. Description of Study Intervention: All 100 eligible patients were randomly divided into two groups (n = 50/each): Patients in the Control group received routine treatment and were administered 0.9% NaCl physiological saline 3 times/day, while the patients in the Navax group received LiveSpo Navax 3 times/day in addition to the same standard of care treatment. The standard treatment regimen typically lasts for 5-7 days, but its duration can be extended based on the severity of the patient's respiratory failure. Study duration: 12 months.

Timeline

Start

2023-07-05

Primary completion

2024-07-27

Completion

2025-03

Publications

• Background Bryce J, Boschi-Pinto C, Shibuya K, Black RE; WHO Child Health Epidemiology Reference Group. WHO estimates of the causes of death in children. Lancet. 2005 Mar 26-Apr 1;365(9465):1147-52. doi: 10.1016/S0140-6736(05)71877-8.
• Background Benguigui Y. [Magnitude and control of acute respiratory infections in children]. Salud Publica Mex. 1988 May-Jun;30(3):362-9. Spanish.
• Background Rudan I, Boschi-Pinto C, Biloglav Z, Mulholland K, Campbell H. Epidemiology and etiology of childhood pneumonia. Bull World Health Organ. 2008 May;86(5):408-16. doi: 10.2471/blt.07.048769.
• Background Do AH, van Doorn HR, Nghiem MN, Bryant JE, Hoang TH, Do QH, Van TL, Tran TT, Wills B, Nguyen VC, Vo MH, Vo CK, Nguyen MD, Farrar J, Tran TH, de Jong MD. Viral etiologies of acute respiratory infections among hospitalized Vietnamese children in Ho Chi Minh City, 2004-2008. PLoS One. 2011 Mar 24;6(3):e18176. doi: 10.1371/journal.pone.0018176.
• Background Bellos A, Mulholland K, O'Brien KL, Qazi SA, Gayer M, Checchi F. The burden of acute respiratory infections in crisis-affected populations: a systematic review. Confl Health. 2010 Feb 11;4:3. doi: 10.1186/1752-1505-4-3.
• Background Gruber C, Keil T, Kulig M, Roll S, Wahn U, Wahn V; MAS-90 Study Group. History of respiratory infections in the first 12 yr among children from a birth cohort. Pediatr Allergy Immunol. 2008 Sep;19(6):505-12. doi: 10.1111/j.1399-3038.2007.00688.x. Epub 2007 Dec 21.
• Background Lin HC, Liu YC, Hsing TY, Chen LL, Liu YC, Yen TY, Lu CY, Chang LY, Chen JM, Lee PI, Huang LM, Lai FP. RSV pneumonia with or without bacterial co-infection among healthy children. J Formos Med Assoc. 2022 Mar;121(3):687-693. doi: 10.1016/j.jfma.2021.08.012. Epub 2021 Aug 24.
• Background Bakaletz LO. Viral-bacterial co-infections in the respiratory tract. Curr Opin Microbiol. 2017 Feb;35:30-35. doi: 10.1016/j.mib.2016.11.003. Epub 2016 Dec 7.
• Background van den Bergh MR, Biesbroek G, Rossen JW, de Steenhuijsen Piters WA, Bosch AA, van Gils EJ, Wang X, Boonacker CW, Veenhoven RH, Bruin JP, Bogaert D, Sanders EA. Associations between pathogens in the upper respiratory tract of young children: interplay between viruses and bacteria. PLoS One. 2012;7(10):e47711. doi: 10.1371/journal.pone.0047711. Epub 2012 Oct 17.
• Background Aston SJ. Pneumonia in the developing world: Characteristic features and approach to management. Respirology. 2017 Oct;22(7):1276-1287. doi: 10.1111/resp.13112. Epub 2017 Jul 6.
• Background Friedman JN, Rieder MJ, Walton JM; Canadian Paediatric Society, Acute Care Committee, Drug Therapy and Hazardous Substances Committee. Bronchiolitis: Recommendations for diagnosis, monitoring and management of children one to 24 months of age. Paediatr Child Health. 2014 Nov;19(9):485-98. doi: 10.1093/pch/19.9.485.
• Background Pochon C, Voigt S. Respiratory Virus Infections in Hematopoietic Cell Transplant Recipients. Front Microbiol. 2019 Jan 9;9:3294. doi: 10.3389/fmicb.2018.03294. eCollection 2018.
• Background Principi N, Cozzali R, Farinelli E, Brusaferro A, Esposito S. Gut dysbiosis and irritable bowel syndrome: The potential role of probiotics. J Infect. 2018 Feb;76(2):111-120. doi: 10.1016/j.jinf.2017.12.013. Epub 2017 Dec 29.
• Background Elshaghabee FMF, Rokana N, Gulhane RD, Sharma C, Panwar H. Bacillus As Potential Probiotics: Status, Concerns, and Future Perspectives. Front Microbiol. 2017 Aug 10;8:1490. doi: 10.3389/fmicb.2017.01490. eCollection 2017.
• 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.
• Background Song M, Hong HA, Huang JM, Colenutt C, Khang DD, Nguyen TV, Park SM, Shim BS, Song HH, Cheon IS, Jang JE, Choi JA, Choi YK, Stadler K, Cutting SM. Killed Bacillus subtilis spores as a mucosal adjuvant for an H5N1 vaccine. Vaccine. 2012 May 9;30(22):3266-77. doi: 10.1016/j.vaccine.2012.03.016. Epub 2012 Mar 22.
• Background Marseglia GL, Tosca M, Cirillo I, Licari A, Leone M, Marseglia A, Castellazzi AM, Ciprandi G. Efficacy of Bacillus clausii spores in the prevention of recurrent respiratory infections in children: a pilot study. Ther Clin Risk Manag. 2007 Mar;3(1):13-7. doi: 10.2147/tcrm.2007.3.1.13.
• Background Lehtoranta L, Pitkaranta A, Korpela R. Probiotics in respiratory virus infections. Eur J Clin Microbiol Infect Dis. 2014 Aug;33(8):1289-302. doi: 10.1007/s10096-014-2086-y. Epub 2014 Mar 18.
• 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.

Drugs

Indications