Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorAnabio R&D
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Other intervention0.9% 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 productIn 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 productIn 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.
Treatment groups
330 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: NavaxExperimental treatment 1 intervention
Group C: Navax-PregMomExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.2
Number of days of inpatient treatment
The total number of days a participant stays in the hospital for treatment during the study period.
Time frame
Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.Secondary outcomes
1
Use of medications and supportive treatments during hospitalization
Percentage of children using various medications (antiviral, antibiotics, and other symptomatic treatments such as antipyretics, anti-inflammatory drugs, anti-allergics, etc.) and supportive treatments (oxygen therapy, nebulization, etc.) throughout the inpatient treatment period, including the starting date of use, type of medication, and total number of days used.
Time frame
Daily assessments will be conducted during hospitalization, from admission (Day 0) through discharge. The duration of hospitalization is variable, averaging 10 days.2
Inflammatory cytokine and IgA levels in clinical samples
Cytokine concentrations, including IL-6 (pg/mL), IL-8 (pg/mL), TNF-α (pg/mL), Immunoglobulin A (IgA) (µg/mL) in nasopharyngeal swabs, IL-10 (pg/mL), IL-17 (pg/mL), IL-23 (pg/mL) in blood, will be measured using ELISA.
Time frame
Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional)3
Presence of probiotic bacterial spores
Presence of beneficial bacterial spores B. subtilis, B. clausii, and B. coagulans in nasopharyngeal swabs and samples measured using Real-time PCR
Time frame
Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional)4
Semi-quantitative changes in respiratory viral and bacterial pathogen loads
Semi-quantitative changes in loads of several common respiratory pathogens, including at least 3 of 6 common viruses (1) RSV, (2) influenza A-B, (3) rhinovirus, (4) adenovirus, (5) parainfluenza virus, (6) Covid-19, and 3 common bacterial co-infections (1) S. pneumoniae, (2) H. influenzae, and (3) Moraxella cattaralis
Time frame
Days 0 and 3 (mandatory), and on discharge days 30 and 60 (optional)Other outcomes
1
Changes in nasal microbiota composition and diversity
Changes in nasal microbiota, analysis of alpha, beta, phylum, family, genus, and species diversity changes using 16S rRNA NGS technique (V3-V4 region), in nasopharyngeal swab samples
Time frame
Day 0 and one of follow-up time points Day 3, 30, or 602
Changes in gut microbiota composition and diversity
Changes in gut microbiota, analysis of alpha, beta, phylum, family, genus, and species diversity changes using 16S rRNA NGS technique (V3-V4 region), in stool samples
Time frame
Day 0 and one of follow-up time points Day 3, 30, or 60 Source ClinicalTrials.gov
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