Completed

Efficacy of Physiological Saline and Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children Aged 2-5, in Son Tay Province, Hanoi

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What is being tested

0.9% NaCl physiological saline

+ Probiotic 1

+ Probiotic 2

DrugCombination Product
Who is being recruted

Infections+1

+ Respiration Disorders

+ Respiratory Tract Diseases

From 2 to 5 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorAnabio R&D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 2, 2024

Actual date on which the first participant was enrolled.

This study explores the potential of using a probiotic nasal spray to help prevent respiratory diseases in young children aged 2 to 5 years old. In Vietnam, children under 5 are particularly vulnerable to respiratory infections like pneumonia and bronchiolitis, especially during certain seasons. While there are vaccines for some respiratory infections, there are none for others like RSV and adenovirus, making prevention challenging. The study is crucial as it investigates whether using probiotics directly in the nose could be a safe and effective method to reduce the number of respiratory diseases in children, potentially minimizing the need for antibiotics and improving overall respiratory health. In this clinical trial, 600 children will be divided into three groups, with each group receiving different treatments. One group will use a saline nasal spray, while the other two groups will use probiotic nasal sprays: LiveSpo Navax or LiveSpo Navax Kid. The trial is double-blind, meaning neither the children nor the researchers know which treatment each child receives, ensuring unbiased results. Over four weeks, the children's health will be closely monitored, with regular check-ups and tests to see if the probiotics help reduce respiratory issues. Parents are asked to avoid giving their children other probiotics or nasal treatments during this period. The study measures the number of respiratory infections, the duration of illness, and any antibiotic use, aiming to provide clear insights into the effectiveness of the probiotic sprays.

Official TitleEfficacy of Physiological Saline and Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children Aged 2-5, in Son Tay Province, Hanoi
NCT06148194
Principal SponsorAnabio R&D
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 5 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsRespiration DisordersRespiratory Tract DiseasesVirus Diseases

Criteria

2 inclusion criteria required to participate
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.

4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
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.

Group II

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.

Group III

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Son Tay Province, Hanoi

Hanoi, VietnamOpen Son Tay Province, Hanoi in Google Maps
CompletedOne Study Center