Efficacy of Physiological Saline and Probiotics (LiveSpo Navax) in Preventing Respiratory Diseases in Children Aged 2-5, in Son Tay Province, Hanoi
0.9% NaCl physiological saline
+ Probiotic 1
+ Probiotic 2
Infections+1
+ Respiration Disorders
+ Respiratory Tract Diseases
Prevention Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalGroup III
ExperimentalStudy 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