Effects of Nasal-spraying LiveSpo Navax in Treatment of Influenza Virus in Children

NCT05378022 | Completed DMC

• 2 other identifiers: 2020S-06.2No. 441/BVNTW-VNCSKTE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Respiratory Tract Infections (ARTIs) in children are common diseases, with influenza virus types A and B is one of the main causes of serious symptoms in young children. Although an influenza vaccine is available, influenza vaccination requires annual injections, which made it difficult for young children to get effectively immunized. Moreover, antiviral nucleotide drugs including Tamiflu (oseltamivir) are unsafe for young children and are recommended only for high-risk patients. Probiotics have emerged as promising safe candidates for supportive treatment of ARTIs and reduction of antibiotic dependence in recent years. Here, investigators propose that direct spraying of probiotics into the nose can be a fast and effective symptomatic treatment for ARTIs due to influenza virus. The aim of the study about to evaluate the effectiveness of nasal-spraying probiotics containing spores of two bacterial strains, Bacillus subtilis and Bacillus clausii in preventing and supporting the treatment of children having acute respiratory symptoms due to influenza infection. Study Population: sample size is 70. Description of Sites: the study is carried out at Vietnam National Children's Hospital. Description of Study Intervention: totally 70 eligible patients are divided randomly into 2 groups (n = 35/group each): Patients in Control group received the routine treatment and three times per day 0.9% NaCl physiological saline while the patients in the Navax group received three times per day LiveSpo Navax in addition to the same standard of care treatment. The standard treatment regimen is 2-5 days but can be extended further depending on the severity of the patient's respiratory failure. Study duration: 15 months

Conditions

Acute Respiratory Tract Infections

Keywords

Influenza Virus (Flu); 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 influenza-infected patients with free respiratory symptoms including runny nose, fever, dry rales, moist rales, fast breath, and fast pulse

  Day 0 to day 5

Secondary Outcomes (7)

• Patient's breath

  Day 0 to day 5

• Patient's pulse

  Day 0 and day 5

• Patient's temperature

  Day 0 and day 5

• Patient's pulse oxygen (SpO2)

  Day 0 to day 5

• Influenza virus concentration

  Day 0 and day 2

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®); expectorant Carbocysteine (Carbothiol®); antiviral Oseltamivir phosphate (Tamiflu®); antibiotics e.g. cefotaxim (Goldcefo®), Amoxicillin / clavulanic acid (Augmentin®) 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 billion CFU/5 mL (LiveSpo®️ Navax): Routine treatment is as follows: Oral administrative drugs: antipyretic paracetamol (Efferegant®); expectorant Carbocysteine (Carbothiol®); antiviral Oseltamivir phosphate (Tamiflu®); antibiotics e.g. cefotaxime (Goldcefo®), Amoxicillin / clavulanic acid (Augmentin®) 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 - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (male/female) aged from 4 months to 7 years
• Admitted to hospital due to upper respiratory infection
• Influenza A and B 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
• Having a history of drug allergies
• Need oxygen therapy
• Discharged before day 2
• 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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MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

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: May 12, 2022
• First Posted: May 17, 2022
• Study Start: December 21, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 22, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

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)