Efficacy of Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children

NCT06148194 | Completed DMC

• 2 other identifiers: TNLS.2023.NPNo. 202/HDDD-VKC
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Respiratory Disease; Respiratory Infections in Children

Keywords

Acute respiratory infection; Prevention; Nasal-spraying probiotics; Bacillus spores; Children; Viruses; Bacterial co-infection

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Weeks 1-2 and 3-4

Secondary Outcomes (6)

• The number of episodes of children with cold/illness/respiratory tract infections.

  2 weeks and 4 weeks

• Duration of illness

  2 weeks and 4 weeks

• Duration of school absence

  2 weeks and 4 weeks

• Duration of respiratory tract disease treatment

  2 weeks and 4 weeks

• Duration of treatment for respiratory tract diseases with each type of medication

  2 weeks and 4 weeks

Other Outcomes (2)

• Changes in the nasal microbiome in children at day 28 compared to day 0.

  Days 0 and 28

• Changes in pro/anti-inflammatory cytokine levels in nasopharyngeal samples at days 0, 14, and 28

  Day 0, 14, and 28

Study Arms (3)

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.

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.

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.

Combination Product: Probiotic 2

Interventions

0.9% NaCl physiological saline DRUG

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.

Also known as: Registration number: VD-32723-19

Control

Probiotic 1 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.

Also known as: Registration number: No.210001337/PCBA-HN

Probiotic 1

Probiotic 2 COMBINATION_PRODUCT

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.

Also known as: Registration number: No. 220002534/PCBA-HN

Probiotic 2

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anabio R&D: lead
• Hanoi Medical University: collaborator

Study Sites (1)

Son Tay Province, Hanoi

Hanoi, 10000, Vietnam

Location

Related Publications (9)

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• 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.

  PMID: 35858943 BACKGROUND

• Tran 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.

  PMID: 37684332 BACKGROUND

MeSH Terms

Conditions

Respiration Disorders; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Infections

Study Officials

• Thu TH Nguyen, Assoc. Prof.

  Hanoi Medical University

  PRINCIPAL INVESTIGATOR

• Anh TV Nguyen, Assoc. Prof.

  Spobio Research Center, Anabio R&D

  PRINCIPAL INVESTIGATOR

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. Only the PI and a data analyst are aware of the group codes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Blind, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 28, 2023
• Study Start: January 2, 2024
• Primary Completion: May 15, 2024
• Study Completion: October 23, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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)