Effects of Nasal-spraying LiveSpo Navax in Treatment of Acute Respiratory Infections in Children

NCT05164692 | Completed DMC

• 2 other identifiers: 2020S-064711/QD-BVNTU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Rationals: Infection with the Respiratory Syncytial Virus (RSV) is one of the most common causes of respiratory tract diseases. However, treatment for pediatric RSV infection remains supportive to prevent co-infection bacteria and respiratory failure. In recent years, preventive and supportive probiotic therapies for respiratory tract infections (RTIs) have been increasingly strengthened, however, the use of oral administrative probiotics as functional foods is effective only for mild symptoms and not applicable for Acute RTIs (ARTIs). Here, we propose that direct spraying of probiotics into the nose can be a fast and effective symptomatic treatment for ARTIs. Objectives: Investigate symptomatic treatment effects of probiotic product LiveSpo Navax, as liquid-suspension form containing Bacillus spores of safe B. subtilis ANA4 and B. clausii ANA39 strains, in children having acute respiratory diseases caused by RSV:

• Primary Objective: Evaluation of improved efficacy and reduced treatment time of LiveSpo Navax in children infected with RSV.
• Secondary Objectives: Measurement of changes in RSV viral load, co-infectious bacterial concentrations, and major cytokine indicators in the nasopharyngeal mucosa before and after 3 days using LiveSpo Navax. Endpoints: Primary endpoint: LiveSpo Navax alleviates RSV-infection symptoms about 25% more effectively, as indicated by 90% of patients using LiveSpo Navax (Navax group) are symptom-free at day 3-6 of intervention depending on symptoms, compared to 65% of patients in Control group. Secondary endpoint: Patients in Navax group had more significant reductions in RSV load (\>10 fold) than patients in Control group at day 3 of intervention. Study Population: Sample size is 100. Description of Sites: The study is carried out at Vietnam National Children's Hospital. Description of Study Intervention: Totally 100 eligible patients are divided randomly into 2 groups (n = 50/group each): Patients in Control group received the routine treatment and three times per day 0.9% NaCl physiological saline while the and patients in Navax group received three times per day LiveSpo Navax in addition to the same standard of care treatment. The standard treatment regimen is 3-6 days but can be extended further depending on the severity of the patients' respiratory failure. Study Duration: 12 months

Conditions

Acute Respiratory Tract Infections

Keywords

Respiratory Syncytial Virus (RSV); Acute Respiratory Tract Infections (ARTIs); Children; Nasal-spraying probiotics; Viral load; Co-infection bacteria; Cytokines; Bacillus spores

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with free respiratory symptoms

  Percentage (%) of RSV-infected patients with free respiratory symptoms including runny nose, chest depression, difficulty breathing, dry rales, and moist rales

  Day 0 to day 6

Secondary Outcomes (7)

• Patient's breath

  Day 0 to day 6

• Patient's pulse

  Day 0 to day 6

• Patient's temperature

  Day 0 to day 6

• Patient's pulse oxygen (SpO2)

  Day 0 to day 6

• RSV concentration

  Day 0 and day 3

Study Arms (2)

Control

PLACEBO COMPARATOR

Control group receives the routine treatment and uses 0.9% NaCl physiological saline: Routine treatment is as follows: * Oral administrative drugs: antipyretic paracetamol (Efferegant®️); anti-inflammatory corticosteroid methylprednisolon; antibiotics e.g. ampicillin and sulbactam complex (Ama-power®️), tobramycin (Medphatobra®️), or cefotaxim (Goldcefo®️), based on the results of antibiotic susceptibility test. * Aerosol therapy: bronchodilator e.g. salbutamol (Ventolin ®️inhaler) or budesonide (Pulmicort ®️Respules).

Drug: 0.9% NaCl physiological saline

Navax

EXPERIMENTAL

Navax group receives the routine treatment and uses NaCl 0.9% plus B. subtilis and B. clausii at 5 billions CFU/5 mL (LiveSpo®️ Navax): Routine treatment is as follows: * Oral administrative drugs: antipyretic paracetamol (Efferegant®️); anti-inflammatory corticosteroid methylprednisolon; antibiotics e.g. ampicillin and sulbactam complex (Ama-power®️), tobramycin (Medphatobra®️), or cefotaxim (Goldcefo®️), based on the results of antibiotic susceptibility test. * Aerosol therapy: bronchodilator e.g. salbutamol (Ventolin ®️inhaler) or budesonide (Pulmicort ®️Respules).

Combination Product: LiveSpo Navax

Interventions

LiveSpo Navax COMBINATION_PRODUCT

In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device product (Product declaration No.210001337/PCBA-HN) under manufacturing standards approved by Hanoi Health Department, Ministry of Health, Vietnam (Certificate No YT117-19) and ISO 13485:2016.

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

Navax

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. VD-32732-19), and then pouring it into the same opaque plastic spraying 10 mL-bottle that is used for LiveSpo Navax.

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

Control

Eligibility Criteria

• Age: 4 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (male/female) aged from 4 to 60 months.
• Admitted hospital due to lower respiratory infection.
• RSV is positive by rapid test.
• Parents of the pediatric patient agree to participate in the study, explain and sign the research consent form.

You may not qualify if:

• Newborn babies.
• Have a history of drug allergy.
• Need oxygen therapy.
• Discharged before day 3.
• Lost to follow-up.
• Withdrawn from the trial.
• Continuing in the trial but missing data.
• Meeting the criteria for psychiatric disorders other than depression and/or anxiety.

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

International Center, Vietnam National Children's Hospital

Hanoi, 100000, Vietnam

Location

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Related Links

• Novel insight on probiotic Bacillus subtilis: mechanism of action and clinical applications.

Study Officials

• Tu T Tran, PhD. MD.

  International Center, Vietnam National Children's Hospital

  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 is unrecognizable to investigators except the PI and analyzer, nurses, patient's parents, and patients due to opaque plastic container.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of International Center, Vietnam National Children's Hospital

Model Details: Blind, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 21, 2021
• Study Start: August 29, 2020
• Primary Completion: June 16, 2021
• Study Completion: August 29, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

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), clinical study peport (CSR). For more information or to submit a request, please contact clinicaltrial.probiotics@gmail.com

Locations

VN (1)