Respiratory DiseaseNCT06148194
Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children
A study testing 0.9% NaCl physiological saline, Probiotic 1 and Probiotic 2 in people with Respiratory Disease and Respiratory Infections in Children, run by Anabio R&D at 1 site in Vietnam.
Trial summary
Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Currently, the prevention of acute respiratory infections in children still faces certain limitations. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Respiratory Infections in Children
- What is being tested?
- 0.9% NaCl physiological saline, Probiotic 1 and Probiotic 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Jan 2024to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children (male/female) aged from 2 to 5 years, currently attending a preschool.
- Parents of the pediatric agree to participate in the study, explain, and sign the research consent form.
Who cannot join
- Children with a history of nasal reconstructive surgery, nasal ulcers, or nasal polyps.
- Children with a history of congenital immunodeficiency or infectious diseases (e.g., HIV).
- Children who regularly use products that may affect the research outcomes (e.g., immunosuppressive/immunostimulant drugs, pain relievers/anti-inflammatory drugs, anti-cough/expectorant drugs, antihistamines, or other probiotics) within 4 weeks before the start of the study.
- Children with co-morbidities that affect cognition and perception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Physiological Saline and Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children Aged 2-5, in Son Tay Province, Hanoi
Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. In recent years, preventive strategies for respiratory inflammation have garnered increasing attention, with probiotics being shown to have the potential to support treatment and prevention \& reduce the risk of recurrent respiratory infections, thus decreasing reliance on antibiotics. Here, the investigators propose that direct nasal spraying of probiotics may be safe and effective in preventing respiratory diseases.
The aim of the study is to evaluate the effectiveness of two types of nasal- praying Bacillus probiotics including LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and LiveSpo Navax Kid (0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing respiratory diseases. Study Population: The sample size is 600. Description of Sites: The study is conducted at preschools in Son Tay Province, Hanoi, Vietnam.
Read more
Description of Study Intervention: A total of 600 eligible children are randomly divided into three groups (n = 200/group each). Children in the Control group received 0.9% NaCl physiological saline twice daily (morning and afternoon), with 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time), continuously for four weeks. Children in the Probiotic 1 group receive LiveSpo Navax product, and children in the Probiotic 2 group receive LiveSpo Navax Kid, with the same dosage and frequency as the Control group.
Study Duration: 12 months.
Read the detailed description
Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Vietnam is one of the 15 countries with the highest pneumonia rates in the world, with an estimated 2.9 million cases occurring annually. The age group most susceptible to acute respiratory infections is children under 5 years old, especially bronchiolitis, which often occurs in children under 2 years old. The incidence of acute respiratory infections varies with the seasons, with the highest prevalence of viral respiratory infections typically occurring during the winter and spring. In tropical regions, acute respiratory infections are more common during the rainy months, while in temperate regions, they are more prevalent during the winter months. Approximately 30-60% of outpatient visits for medical care are due to acute respiratory infections.
Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. Here, the investigators propose that direct nasal spraying of probiotics may be a safe and effective method for preventing respiratory diseases.
The objective of this study is to investigate the safety and preventive effects of two types of nasal-spraying Bacillus probiotics: LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and LiveSpo Navax Kid (containing 0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing respiratory diseases in healthy children attending preschools. The investigators will evaluate the preventive efficacy in terms of reducing the number of respiratory disease episodes and the number of courses of antibiotics in children after 2 weeks and 4 weeks of using LiveSpo Navax and LiveSpo Navax Kid.
A randomized, double-blind, and controlled clinical trial will be conducted. Parents of the will be required to provide various information about their children, including their full names, sex, ages, respiratory infection history, and history of antibiotic use... After obtaining informed consent, 600 children will be randomly assigned to three groups (n = 200/group): the control group (referred to as the "Control" group) will receive 0.9% NaCl physiological saline, the experimental group 1 (referred to as the "Probiotic 1" group) will receive the probiotic LiveSpo Navax product, and the experimental group 2 (referred to as the "Probiotic 2" group) will receive the probiotic LiveSpo Navax Kid. Children will be provided with coded nasal sprays in blinded samples to ensure the objectivity of the study. Clinical examinations and monitoring will be conducted after 2 weeks and 4 weeks of the experiment. Nasopharyngeal samples will be collected at the same time as the clinical examinations to assess the presence of probiotic spores in the children's nasal mucosa. During the trial, children's typical clinical symptoms of respiratory tract infections are monitored, including runny nose, stuffy nose, sneezing, sore throat, cough, and fatigue. Data is collected on the number of cold or illness episodes, the average duration of each illness episode, the number of days absent from school, and medication history after 2 weeks and 4 weeks of participating in the study. The children's health conditions are observed by caregivers, and the information is recorded in medical records. During this study, parents or caregivers are asked to refrain from giving their children other probiotics, whether via nasal spray or oral administration, and to avoid cleaning their children's noses with other 0.9% NaCl physiological saline sprayers. Data collection and statistical analysis will involve collecting individual medical records and systematically organizing the children's information into a dataset.
The prevention efficacy of LiveSpo Navax product (Probiotic 1 group) and LiveSpo Navax Kid (Probiotic 2 group) is evaluated and compared to 0.9% NaCl physiological saline (Control group) based on the following clinical and survey criteria: (i) reduction in the percentage (%) of children with respiratory infections; (ii) reduction in the number of colds, illnesses, or respiratory tract infections in children; (iii) reduction in the duration of medication usage and the number of medication episodes in the treatment of respiratory diseases. Tabular analysis is performed on dichotomous variables using the χ2 test or Fisher's exact test when the expected value of any cell is below five. Continuous variables are compared using either the t-test or the Mann-Whitney test when the data is not normally distributed. Statistical and graphical analyses are conducted using GraphPad Prism v8.4.3 software (GraphPad Software, CA, USA). The significance level for all analyses is set at p < 0.05.
Detection of B. subtilis ANA4 and B. clausii ANA39 in nasopharyngeal samples was conducted at 2 weeks and 4 weeks using real-time PCR with SYBR Green following the ISO 17025:2017 guidelines. This testing was performed at the Spobiotic Research Center.
- Being tested
- 0.9% NaCl physiological saline, Probiotic 1, Probiotic 2
- Keywords
- Acute respiratory infection, Prevention, Nasal-spraying probiotics, Bacillus spores, Children, Viruses, Bacterial co-infection
- Medical subject headings
- Respiration Disorders, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% NaCl physiological salineDrug
Also called Registration number: VD-32723-19
Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 30 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque plastic spraying 30 mL-bottle that is used for probiotic 1 and 2.
Probiotic 1Combination product
Also called Registration number: No.210001337/PCBA-HN
In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device (Product declaration: No. 210001337/PCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax product is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL.
Probiotic 2Combination product
Also called Registration number: No. 220002534/PCBA-HN
In Vietnam, LiveSpo Navax Kid is manufactured as a Class-A medical device (Product declaration: No. 220002534/PCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax Kid is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 0.6 billion CFU/mL x 30 mL.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control group receives 0.9% NaCl physiological saline. Caregivers will spray the children twice daily (morning and afternoon), administering 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time) for a continuous period of 4 weeks, starting from the time of study participation. Receives: Drug: 0.9% NaCl physiological saline |
| Probiotic 1 | Experimental | The Probiotic 1 group receives LiveSpo® Navax product which is NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL. Caregivers will spray the children twice daily (morning and afternoon), administering 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time) for a continuous period of 4 weeks, starting from the time of study participation. Receives: Combination Product: Probiotic 1 |
| Probiotic 2 | Experimental | The Probiotic 2 group receives LiveSpo® Navax Kid product which is NaCl 0.9% plus B. subtilis and B. clausii at 0.6 billion CFU/mL x 30 mL. Caregivers will spray the children twice daily (morning and afternoon), administering 2 sprays in the nose and 2 sprays in each nostril, and 2 sprays in the throat each time (totally 6 sprays each time) for a continuous period of 4 weeks, starting from the time of study participation. Receives: Combination Product: Probiotic 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children with respiratory infections
Percentage (%) of children with respiratory infections (runny nose, tonsillitis, rhinosinusitis, hoarseness, stuffy nose, sneezing, sore throat, cough, feeling tired...) after 2 weeks and 4 weeks of participating in the study
Measured: Days 0, 14, and 28
Incidence of medication intakes (%)
Incidence of medication intakes (%) including antibiotics, cough suppressants/expectorants, anti-inflammatory drugs, antihistamines, antipyretics... between weeks 1-2 and weeks 3-4.
Measured: Weeks 1-2 and 3-4
Secondary outcomes (6)
The number of episodes of children with cold/illness/respiratory tract infections.
The number of episodes of children with cold/illness/respiratory tract infections after 2 weeks and after 4 weeks of participating in the study
Measured: 2 weeks and 4 weeks
Duration of illness
The average number of days per episode of cold/illness/respiratory tract infections at 2 weeks and after 4 weeks of participating in the study
Measured: 2 weeks and 4 weeks
Duration of school absence
The average number of days children have to be absent from school due to cold/illness/respiratory tract infections at 2 weeks and after 4 weeks of participating in the study
Measured: 2 weeks and 4 weeks
Duration of respiratory tract disease treatment
The average number of days children undergo treatment for each respiratory tract disease (bronchiolitis, pneumonia, pharyngitis, otitis media, asthma...) after 2 weeks and after 4 weeks of participating in the study
Measured: 2 weeks and 4 weeks
Duration of treatment for respiratory tract diseases with each type of medication
The average number of days children undergo treatment with each type of medication (antibiotics, anti-inflammatory, antipyretics, expectorants, infusion, bronchodilators...) after 2 weeks and after 4 weeks of participating in the study
Measured: 2 weeks and 4 weeks
Percentage (%) of children infected with viral and bacterial infections
Percentage (%) of children infected with viruses (RSV, Flu, Rhinovirus) at days 0, 14, and 28.
Percentage (%) of children infected with bacteria (M. catarrhalis, H. influenzae, S. pneumoniae) at days 0, 14, and 28.
Percentage (%) of children infected with viral and bacterial co-infections at days 0, 14, and 28.
Measured: Days 0, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start2 Jan 2024
- Primary completion15 May 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blind, randomized, and controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anabio R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanoi Medical University
- Responsible party
- Sponsor
- Investigators
- Thu TH Nguyen, Assoc. Prof., Principal investigator, Hanoi Medical UniversityAnh TV Nguyen, Assoc. Prof., Principal investigator, Spobio Research Center, Anabio R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148194
- Sponsor's protocol ID
- TNLS.2023.NP
- Other IDs
- No. 202/HDDD-VKC
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Michelow IC, Olsen K, Lozano J, Rollins NK, Duffy LB, Ziegler T, Kauppila J, Leinonen M, McCracken GH Jr. Epidemiology and clinical characteristics of community-acquired pneumonia in hospitalized children. Pediatrics. 2004 Apr;113(4):701-7. doi: 10.1542/peds.113.4.701.
PubMed 15060215Shahbazi R, Yasavoli-Sharahi H, Alsadi N, Ismail N, Matar C. Probiotics in Treatment of Viral Respiratory Infections and Neuroinflammatory Disorders. Molecules. 2020 Oct 22;25(21):4891. doi: 10.3390/molecules25214891.
PubMed 33105830Greenwood B. The epidemiology of pneumococcal infection in children in the developing world. Philos Trans R Soc Lond B Biol Sci. 1999 Apr 29;354(1384):777-85. doi: 10.1098/rstb.1999.0430.
PubMed 10365403Shi T, McAllister DA, O'Brien KL, Simoes EAF, Madhi SA, Gessner BD, Polack FP, Balsells E, Acacio S, Aguayo C, Alassani I, Ali A, Antonio M, Awasthi S, Awori JO, Azziz-Baumgartner E, Baggett HC, Baillie VL, Balmaseda A, Barahona A, Basnet S, Bassat Q, Basualdo W, Bigogo G, Bont L, Breiman RF, Brooks WA, Broor S, Bruce N, Bruden D, Buchy P, Campbell S, Carosone-Link P, Chadha M, Chipeta J, Chou M, Clara W, Cohen C, de Cuellar E, Dang DA, Dash-Yandag B, Deloria-Knoll M, Dherani M, Eap T, Ebruke BE, Echavarria M, de Freitas Lazaro Emediato CC, Fasce RA, Feikin DR, Feng L, Gentile A, Gordon A, Goswami D, Goyet S, Groome M, Halasa N, Hirve S, Homaira N, Howie SRC, Jara J, Jroundi I, Kartasasmita CB, Khuri-Bulos N, Kotloff KL, Krishnan A, Libster R, Lopez O, Lucero MG, Lucion F, Lupisan SP, Marcone DN, McCracken JP, Mejia M, Moisi JC, Montgomery JM, Moore DP, Moraleda C, Moyes J, Munywoki P, Mutyara K, Nicol MP, Nokes DJ, Nymadawa P, da Costa Oliveira MT, Oshitani H, Pandey N, Paranhos-Baccala G, Phillips LN, Picot VS, Rahman M, Rakoto-Andrianarivelo M, Rasmussen ZA, Rath BA, Robinson A, Romero C, Russomando G, Salimi V, Sawatwong P, Scheltema N, Schweiger B, Scott JAG, Seidenberg P, Shen K, Singleton R, Sotomayor V, Strand TA, Sutanto A, Sylla M, Tapia MD, Thamthitiwat S, Thomas ED, Tokarz R, Turner C, Venter M, Waicharoen S, Wang J, Watthanaworawit W, Yoshida LM, Yu H, Zar HJ, Campbell H, Nair H; RSV Global Epidemiology Network. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017 Sep 2;390(10098):946-958. doi: 10.1016/S0140-6736(17)30938-8. Epub 2017 Jul 7.
PubMed 28689664Domachowske JB, Anderson EJ, Goldstein M. The Future of Respiratory Syncytial Virus Disease Prevention and Treatment. Infect Dis Ther. 2021 Mar;10(Suppl 1):47-60. doi: 10.1007/s40121-020-00383-6. Epub 2021 Mar 3.
PubMed 33656652Tiurin EA. [Effect of the use of dysentery divaccine as therapy in experimental radiation sickness on the immune response to heterologous antigens]. Radiobiologiia. 1982 May-Jun;22(3):395-8. No abstract available. Russian.
PubMed 7122849Lee NK, Kim WS, Paik HD. Bacillus strains as human probiotics: characterization, safety, microbiome, and probiotic carrier. Food Sci Biotechnol. 2019 Oct 8;28(5):1297-1305. doi: 10.1007/s10068-019-00691-9. eCollection 2019 Oct.
PubMed 31695928Tran 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.
PubMed 35858943Tran TT, Phung TTB, Tran DM, Bui HT, Nguyen PTT, Vu TT, Ngo NTP, Nguyen MT, Nguyen AH, Nguyen ATV. Efficient symptomatic treatment and viral load reduction for children with influenza virus infection by nasal-spraying Bacillus spore probiotics. Sci Rep. 2023 Sep 8;13(1):14789. doi: 10.1038/s41598-023-41763-5.
PubMed 37684332
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physiological Saline and Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children Aged 2-5, in Son Tay Province, Hanoi
- ClinicalTrials.gov ID
- NCT06148194
- Acronym / sponsor ID
- TNLS.2023.NP
- Keywords
- Acute respiratory infection, Prevention, Nasal-spraying probiotics, Bacillus spores, Children, Viruses, Bacterial co-infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Anabio R&DIndustry (pharma, biotech, devices)
- Collaborators
- Hanoi Medical University
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. In recent years, preventive strategies for respiratory inflammation have garnered increasing attention, with probiotics being shown to have the potential to support treatment and prevention \& reduce the risk of recurrent respiratory infections, thus decreasing reliance on antibiotics. Here, the investigators propose that direct nasal spraying of probiotics may be safe and effective in preventing respiratory diseases.
The aim of the study is to evaluate the effectiveness of two types of nasal- praying Bacillus probiotics including LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and LiveSpo Navax Kid (0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing respiratory diseases. Study Population: The sample size is 600. Description of Sites: The study is conducted at preschools in Son Tay Province, Hanoi, Vietnam.
Description of Study Intervention: A total of 600 eligible children are randomly divided into three groups (n = 200/group each). Children in the Control group received 0.9% NaCl physiological saline twice daily (morning and afternoon), with 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time), continuously for four weeks. Children in the Probiotic 1 group receive LiveSpo Navax product, and children in the Probiotic 2 group receive LiveSpo Navax Kid, with the same dosage and frequency as the Control group.
Study Duration: 12 months.
Detailed description
Acute respiratory infections are common diseases worldwide with the highest incidence and mortality rates, especially among children. Vietnam is one of the 15 countries with the highest pneumonia rates in the world, with an estimated 2.9 million cases occurring annually. The age group most susceptible to acute respiratory infections is children under 5 years old, especially bronchiolitis, which often occurs in children under 2 years old. The incidence of acute respiratory infections varies with the seasons, with the highest prevalence of viral respiratory infections typically occurring during the winter and spring. In tropical regions, acute respiratory infections are more common during the rainy months, while in temperate regions, they are more prevalent during the winter months. Approximately 30-60% of outpatient visits for medical care are due to acute respiratory infections.
Currently, the prevention of acute respiratory infections in children still faces certain limitations. Although there is a vaccine available for influenza, there are no vaccines yet for RSV and adenovirus in children, and influenza vaccination needs to be repeated annually to achieve optimal effectiveness. Therefore, maintaining respiratory and throat hygiene is essential for both treatment and prevention, ensuring respiratory health for children and reducing the risk of bacterial co-infections. Here, the investigators propose that direct nasal spraying of probiotics may be a safe and effective method for preventing respiratory diseases.
The objective of this study is to investigate the safety and preventive effects of two types of nasal-spraying Bacillus probiotics: LiveSpo Navax (1 billion/mL x 30 mL B. subtilis and B. clausii) and LiveSpo Navax Kid (containing 0.6 billion/mL x 30 mL B. subtilis and B. clausii) in preventing respiratory diseases in healthy children attending preschools. The investigators will evaluate the preventive efficacy in terms of reducing the number of respiratory disease episodes and the number of courses of antibiotics in children after 2 weeks and 4 weeks of using LiveSpo Navax and LiveSpo Navax Kid.
A randomized, double-blind, and controlled clinical trial will be conducted. Parents of the will be required to provide various information about their children, including their full names, sex, ages, respiratory infection history, and history of antibiotic use... After obtaining informed consent, 600 children will be randomly assigned to three groups (n = 200/group): the control group (referred to as the "Control" group) will receive 0.9% NaCl physiological saline, the experimental group 1 (referred to as the "Probiotic 1" group) will receive the probiotic LiveSpo Navax product, and the experimental group 2 (referred to as the "Probiotic 2" group) will receive the probiotic LiveSpo Navax Kid. Children will be provided with coded nasal sprays in blinded samples to ensure the objectivity of the study. Clinical examinations and monitoring will be conducted after 2 weeks and 4 weeks of the experiment. Nasopharyngeal samples will be collected at the same time as the clinical examinations to assess the presence of probiotic spores in the children's nasal mucosa. During the trial, children's typical clinical symptoms of respiratory tract infections are monitored, including runny nose, stuffy nose, sneezing, sore throat, cough, and fatigue. Data is collected on the number of cold or illness episodes, the average duration of each illness episode, the number of days absent from school, and medication history after 2 weeks and 4 weeks of participating in the study. The children's health conditions are observed by caregivers, and the information is recorded in medical records. During this study, parents or caregivers are asked to refrain from giving their children other probiotics, whether via nasal spray or oral administration, and to avoid cleaning their children's noses with other 0.9% NaCl physiological saline sprayers. Data collection and statistical analysis will involve collecting individual medical records and systematically organizing the children's information into a dataset.
The prevention efficacy of LiveSpo Navax product (Probiotic 1 group) and LiveSpo Navax Kid (Probiotic 2 group) is evaluated and compared to 0.9% NaCl physiological saline (Control group) based on the following clinical and survey criteria: (i) reduction in the percentage (%) of children with respiratory infections; (ii) reduction in the number of colds, illnesses, or respiratory tract infections in children; (iii) reduction in the duration of medication usage and the number of medication episodes in the treatment of respiratory diseases. Tabular analysis is performed on dichotomous variables using the χ2 test or Fisher's exact test when the expected value of any cell is below five. Continuous variables are compared using either the t-test or the Mann-Whitney test when the data is not normally distributed. Statistical and graphical analyses are conducted using GraphPad Prism v8.4.3 software (GraphPad Software, CA, USA). The significance level for all analyses is set at p < 0.05.
Detection of B. subtilis ANA4 and B. clausii ANA39 in nasopharyngeal samples was conducted at 2 weeks and 4 weeks using real-time PCR with SYBR Green following the ISO 17025:2017 guidelines. This testing was performed at the Spobiotic Research Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Blind, randomized, and controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: 0.9% NaCl physiological salineThe control group receives 0.9% NaCl physiological saline. Caregivers will spray the children twice daily (morning and afternoon), administering 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time) for a continuous period of 4 weeks, starting from the time of study participation. |
| Probiotic 1 | Experimental | Combination Product: Probiotic 1The Probiotic 1 group receives LiveSpo® Navax product which is NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL. Caregivers will spray the children twice daily (morning and afternoon), administering 2 sprays in each nostril and 2 sprays in the throat each time (totally 6 sprays each time) for a continuous period of 4 weeks, starting from the time of study participation. |
| Probiotic 2 | Experimental | Combination Product: Probiotic 2The Probiotic 2 group receives LiveSpo® Navax Kid product which is NaCl 0.9% plus B. subtilis and B. clausii at 0.6 billion CFU/mL x 30 mL. Caregivers will spray the children twice daily (morning and afternoon), administering 2 sprays in the nose and 2 sprays in each nostril, and 2 sprays in the throat each time (totally 6 sprays each time) for a continuous period of 4 weeks, starting from the time of study participation. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children (male/female) aged from 2 to 5 years, currently attending a preschool.
- Parents of the pediatric agree to participate in the study, explain, and sign the research consent form.
Key exclusion criteria (4 listed)
- Children with a history of nasal reconstructive surgery, nasal ulcers, or nasal polyps.
- Children with a history of congenital immunodeficiency or infectious diseases (e.g., HIV).
- Children who regularly use products that may affect the research outcomes (e.g., immunosuppressive/immunostimulant drugs, pain relievers/anti-inflammatory drugs, anti-cough/expectorant drugs, antihistamines, or other probiotics) within 4 weeks before the start of the study.
- Children with co-morbidities that affect cognition and perception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% NaCl physiological salineAlso: Registration number: VD-32723-19Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 30 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque plastic spraying 30 mL-bottle that is used for probiotic 1 and 2. | Drug | Control |
| Probiotic 1Also: Registration number: No.210001337/PCBA-HNIn Vietnam, LiveSpo Navax is manufactured as a Class-A medical device (Product declaration: No. 210001337/PCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax product is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU/mL x 30 mL. | Combination product | Probiotic 1 |
| Probiotic 2Also: Registration number: No. 220002534/PCBA-HNIn Vietnam, LiveSpo Navax Kid is manufactured as a Class-A medical device (Product declaration: No. 220002534/PCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax Kid is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 0.6 billion CFU/mL x 30 mL. | Combination product | Probiotic 2 |
Primary outcome
Percentage of children with respiratory infections
Time frame: Days 0, 14, and 28
Percentage (%) of children with respiratory infections (runny nose, tonsillitis, rhinosinusitis, hoarseness, stuffy nose, sneezing, sore throat, cough, feeling tired...) after 2 weeks and 4 weeks of participating in the study
Incidence of medication intakes (%)
Time frame: Weeks 1-2 and 3-4
Incidence of medication intakes (%) including antibiotics, cough suppressants/expectorants, anti-inflammatory drugs, antihistamines, antipyretics... between weeks 1-2 and weeks 3-4.
6 secondary outcomes
The number of episodes of children with cold/illness/respiratory tract infections.
Time frame: 2 weeks and 4 weeks
Duration of illness
Time frame: 2 weeks and 4 weeks
Duration of school absence
Time frame: 2 weeks and 4 weeks
Duration of respiratory tract disease treatment
Time frame: 2 weeks and 4 weeks
Duration of treatment for respiratory tract diseases with each type of medication
Time frame: 2 weeks and 4 weeks
Percentage (%) of children infected with viral and bacterial infections
Time frame: Days 0, 14, and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 15060215Michelow IC, Olsen K, Lozano J, Rollins NK, Duffy LB, Ziegler T, Kauppila J, Leinonen M, McCracken GH Jr. Epidemiology and clinical characteristics of community-acquired pneumonia in hospitalized children. Pediatrics. 2004 Apr;113(4):701-7. doi: 10.1542/peds.113.4.701.
- Background: PubMed 33105830Shahbazi R, Yasavoli-Sharahi H, Alsadi N, Ismail N, Matar C. Probiotics in Treatment of Viral Respiratory Infections and Neuroinflammatory Disorders. Molecules. 2020 Oct 22;25(21):4891. doi: 10.3390/molecules25214891.
- Background: PubMed 10365403Greenwood B. The epidemiology of pneumococcal infection in children in the developing world. Philos Trans R Soc Lond B Biol Sci. 1999 Apr 29;354(1384):777-85. doi: 10.1098/rstb.1999.0430.
- Background: PubMed 28689664Shi T, McAllister DA, O'Brien KL, Simoes EAF, Madhi SA, Gessner BD, Polack FP, Balsells E, Acacio S, Aguayo C, Alassani I, Ali A, Antonio M, Awasthi S, Awori JO, Azziz-Baumgartner E, Baggett HC, Baillie VL, Balmaseda A, Barahona A, Basnet S, Bassat Q, Basualdo W, Bigogo G, Bont L, Breiman RF, Brooks WA, Broor S, Bruce N, Bruden D, Buchy P, Campbell S, Carosone-Link P, Chadha M, Chipeta J, Chou M, Clara W, Cohen C, de Cuellar E, Dang DA, Dash-Yandag B, Deloria-Knoll M, Dherani M, Eap T, Ebruke BE, Echavarria M, de Freitas Lazaro Emediato CC, Fasce RA, Feikin DR, Feng L, Gentile A, Gordon A, Goswami D, Goyet S, Groome M, Halasa N, Hirve S, Homaira N, Howie SRC, Jara J, Jroundi I, Kartasasmita CB, Khuri-Bulos N, Kotloff KL, Krishnan A, Libster R, Lopez O, Lucero MG, Lucion F, Lupisan SP, Marcone DN, McCracken JP, Mejia M, Moisi JC, Montgomery JM, Moore DP, Moraleda C, Moyes J, Munywoki P, Mutyara K, Nicol MP, Nokes DJ, Nymadawa P, da Costa Oliveira MT, Oshitani H, Pandey N, Paranhos-Baccala G, Phillips LN, Picot VS, Rahman M, Rakoto-Andrianarivelo M, Rasmussen ZA, Rath BA, Robinson A, Romero C, Russomando G, Salimi V, Sawatwong P, Scheltema N, Schweiger B, Scott JAG, Seidenberg P, Shen K, Singleton R, Sotomayor V, Strand TA, Sutanto A, Sylla M, Tapia MD, Thamthitiwat S, Thomas ED, Tokarz R, Turner C, Venter M, Waicharoen S, Wang J, Watthanaworawit W, Yoshida LM, Yu H, Zar HJ, Campbell H, Nair H; RSV Global Epidemiology Network. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017 Sep 2;390(10098):946-958. doi: 10.1016/S0140-6736(17)30938-8. Epub 2017 Jul 7.
- Background: PubMed 33656652Domachowske JB, Anderson EJ, Goldstein M. The Future of Respiratory Syncytial Virus Disease Prevention and Treatment. Infect Dis Ther. 2021 Mar;10(Suppl 1):47-60. doi: 10.1007/s40121-020-00383-6. Epub 2021 Mar 3.
- Background: PubMed 7122849Tiurin EA. [Effect of the use of dysentery divaccine as therapy in experimental radiation sickness on the immune response to heterologous antigens]. Radiobiologiia. 1982 May-Jun;22(3):395-8. No abstract available. Russian.
- Background: PubMed 31695928Lee NK, Kim WS, Paik HD. Bacillus strains as human probiotics: characterization, safety, microbiome, and probiotic carrier. Food Sci Biotechnol. 2019 Oct 8;28(5):1297-1305. doi: 10.1007/s10068-019-00691-9. eCollection 2019 Oct.
- Background: PubMed 35858943Tran 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: PubMed 37684332Tran TT, Phung TTB, Tran DM, Bui HT, Nguyen PTT, Vu TT, Ngo NTP, Nguyen MT, Nguyen AH, Nguyen ATV. Efficient symptomatic treatment and viral load reduction for children with influenza virus infection by nasal-spraying Bacillus spore probiotics. Sci Rep. 2023 Sep 8;13(1):14789. doi: 10.1038/s41598-023-41763-5.
- Individual participant dataSharing planned: Yes. Data or samples share that will be coded, with no PHI include. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thu TH Nguyen, Assoc. Prof. principal investigator
Hanoi Medical University
Anh TV Nguyen, Assoc. Prof. principal investigator
Spobio Research Center, Anabio R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.9% NaCl physiological saline, Probiotic 1 and Probiotic 2 in people with Respiratory Disease and Respiratory Infections in Children, run by Anabio R&D at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children with respiratory infections (time frame: Days 0, 14, and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06148194, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.