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

Sponsor
Anabio R&D
Study ID
NCT07399717
Status
Not Yet Recruiting

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Conditions

  • Pneumonia
  • Pneumonia in Children

Eligibility Criteria

Sex
ALL
Age
6 Months - 36 Months
Healthy Volunteers
Not accepted

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.
  • 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-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.

Study Details

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.

Key Dates

First listed
Feb 10, 2026
Start date
Jan 26, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    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.
  • Experimental: Navax
    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.
  • Experimental: Navax-PregMom
    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.

Primary Outcome Measure

Number of days with typical clinical symptoms of pneumonia [ Time Frame: Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days. ]

Central Contacts

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