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

NCT07399717 | Not Yet Recruiting DMC

• 1 other identifier: TNLS.2026.SNPT
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia; Pneumonia in Children

Keywords

Acute respiratory infection; Adjunctive Treatment; Prevention; Nasal-oropharyngeal; Probiotic spray; Oral probiotic suspension; Bacillus spores; Children; Respiratory viruses; Bacterial co-infection

Outcome Measures

Primary Outcomes (2)

• Number of days with typical clinical symptoms of pneumonia

  Symptoms to be assessed include fever, cough, tachypnea, chest retraction, wheezing, crackles, moist rales, diarrhea, etc.

  Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.

• Number of days of inpatient treatment

  The total number of days a participant stays in the hospital for treatment during the study period.

  Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.

Secondary Outcomes (9)

• Use of medications and supportive treatments during hospitalization

  Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.

• Inflammatory cytokine and IgA levels in clinical samples

  Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional)

• Presence of probiotic bacterial spores

  Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional)

• Semi-quantitative changes in respiratory viral and bacterial pathogen loads

  Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional)

• Proportion of children with diarrheal symptoms during hospitalization

  Daily assessments will occur during hospitalization, from admission (Day 0) until discharge. The duration of hospitalization is variable, averaging 10 days.

Other Outcomes (2)

• Changes in nasal microbiota composition and diversity

  Day 0 and one of follow-up time points Day 3, 30, or 60

• Changes in gut microbiota composition and diversity

  Day 0 and one of follow-up time points Day 3, 30, or 60

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The placebo group receives 0.9% NaCl physiological saline. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 sprays in the throat each time (totally 6 sprays each time) for 8 weeks. The placebo group also receives oral Reverse Osmosis water twice daily, 5 mL per dose, for 8 weeks The Placebo group receives standard pneumonia treatment: oxygen (SpO2 \< 92%) and antibiotics (ampicillin/sulbactam, with or without aminoglycosides/third-generation cephalosporins). Vancomycin/macrolides cover staphylococcal/atypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids/electrolytes, nutrition, physiotherapy. Bronchodilators/corticosteroids are used for bronchospasm or severe pneumonia.

Other: Placebo

Navax

EXPERIMENTAL

The Navax 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 three times daily, administering 3 sprays in each nostril and 3 in the throat, for 8 weeks. The Navax group also receives oral RO water twice daily, 5 mL per dose, for 8 weeks. The Navax group receives standard pneumonia treatment: oxygen (SpO2 \< 92%) and antibiotics (ampicillin/sulbactam, with or without aminoglycosides/third-generation cephalosporins). Vancomycin/macrolides cover staphylococcal/atypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids/electrolytes, nutrition, physiotherapy. Bronchodilators/corticosteroids are used for bronchospasm or severe pneumonia.

Combination Product: Navax

Navax-PregMom

EXPERIMENTAL

The Navax-PregMom 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 three times daily, administering 3 sprays in each nostril and 3 sprays in the throat each time for 8 weeks. The Navax-PregMom group is also given oral medication with LiveSpo® Preg-Mom which is RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU/5mL. The children will receive the probiotic twice daily, with 1 vial per dosefor 8 weeks. The Navax-PregMom group receives standard pneumonia treatment: oxygen (SpO2 \< 92%) and antibiotics (ampicillin/sulbactam, with or without aminoglycosides/third-generation cephalosporins). Vancomycin/macrolides cover staphylococcal/atypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids/electrolytes, nutrition, physiotherapy. Bronchodilators/corticosteroids are used for bronchospasm or severe pneumonia.

Combination Product: Navax-PregMom

Interventions

Placebo OTHER

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 20 mL-bottle that is used for nasal-oropharyngeal probiotic spray. Reverse Osmosis water (Aquafina, PepsiCo) is produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM but contain 5 mL of high-quality RO water from Aquafina.

Placebo

Navax COMBINATION_PRODUCT

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 20 mL. RO water (Aquafina, PepsiCo) produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM but contain 5 mL of high-quality RO water from Aquafina.

Navax

Navax-PregMom COMBINATION_PRODUCT

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. LiveSpo PREG-MOM has a registration number 7695/2020/ĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.

Navax-PregMom

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (male/female) aged 6-36 months diagnosed and hospitalized for treatment for pneumonia.
• Parents or guradians of the children agree to participate in the study, explain, and sign the research consent form.

You may not qualify if:

• Children who need ventilator support.
• Children who have had rhinoplasty surgery, nasal ulcers, nasal polyps or any nasal deformity that affects the use of the study product.
• Children who get transferred or leave the treatment unit (not for professional reasons).
• Children who have experienced congenital immunodeficiency or infectious disease (eg, HIV).
• Children who are concurrently participating in another clinical trial or participated in a clinical trial within 30 days before selection.
• Children who are under long-term medication (more than 7 consecutive days) within 30 days before selection.
• Children with allergy or hypersensitivity to any ingredient of the study product.

Sponsors & Collaborators

• Anabio R&D: lead

Study Sites (1)

Phu Tho Provincial Obstetrics and Pediatrics Hospitals

Phú Thọ, Vietnam

Location

Related Publications (12)

• 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. PMID: 36618370; PMCID: PMC9813340.

  BACKGROUND

• Ness-Cochinwala M, Totapally BR. A Comprehensive Review of Pediatric Necrotizing Pneumonia. Children. 2025; 12(9):1248. doi.org/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. PMID: 36265520; PMCID: PMC9742763.

  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. PMID: 37082704; PMCID: PMC10110918.

  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. PMID: 41156761; PMCID: PMC12566155.

  BACKGROUND

• Khieu, T.H., Le, D.P., Nguyen, B.T. et al. Alleviating symptoms of paediatric acute rhinosinusitis and acute otitis media with otorrhea using nasal-spraying Bacillus probiotics: a randomized controlled trial. Sci Rep 15, 3410 (2025). https://doi.org/10.1038/s41598-025-87372-2

  BACKGROUND

• Zou, Y., Huang, F., Sun, J. et al. The role of IFN-γ/CXCL10 axis in Mycoplasma pneumonia infection. Sci Rep 15, 2671 (2025). https://doi.org/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. PMID: 38077401; PMCID: PMC10702770.

  BACKGROUND

• Thi Le, H., Thi Bich Phung, T., Thi Bui, H. et al. Nasal-spraying Bacillus spore probiotics for pneumonia in children with respiratory syncytial virus and bacterial co-infections: a randomized clinical trial. Commun Med 5, 336 (2025). https://doi.org/10.1038/s43856-025-01029-9

  BACKGROUND

• Tran, X.D., Hoang, VT., Goumballa, N. et al. Viral and bacterial microorganisms in Vietnamese children with severe and non-severe pneumonia. Sci Rep 14, 120 (2024). https://doi.org/10.1038/s41598-023-50657-5

  BACKGROUND

• Tran, D.M., Tran, T.T., Phung, T.T.B. et al. Nasal-spraying Bacillus spores as an effective symptomatic treatment for children with acute respiratory syncytial virus infection. Sci Rep 12, 12402 (2022). https://doi.org/10.1038/s41598-022-16136-z

  BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Loc V Nguyen, MD.

  Phu Tho Provincial Obstetrics and Pediatrics Hospitals

  PRINCIPAL INVESTIGATOR

• Anh TV Nguyen, Assoc. Prof

  Spobio Research Center, Anabio R&D

  STUDY CHAIR

Central Study Contacts

Loc V Nguyen, MD.

CONTACT

+84986911091; drlocnhi@gmail.com

Cong M Nguyen, MD.

CONTACT

+84981241023; congminh.dhyd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: LiveSpo Navax and placebo 0.9% NaCl physiological saline are indistinguishable regarding taste and smell. The color and turbidity of LiveSpo Navax suspension are unrecognizable to investigators, trainers, child caregivers, children's parents, and children due to opaque plastic container. Similarly, LiveSpo Preg-Mom and oral reverse osmosis (RO) water were matched in sensory characteristics and packaging, thereby maintaining blinding of investigators, caregivers, parents, and participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Blinded, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 10, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a study protocol, informed consent form (ICF), and clinical study reports (CSR). For more information or to submit a request, please contact anabio.rd2021@gmail.com

Locations

VN (1)