Investigation of preventing effect of probiotic nasal spray in COVID-19 and other common respiratory viruses
Design
Randomized, superiority, parallel group trial with blinded outcome assessment.
90 participants; phase 3; simple randomization- triple blinded
Settings and conduct
Allergy clinic of Akbar children's hospital, Mashhad University of Medical Sciences university. Participants are children aged 6-18 years old with asthma diagnosis according GINA 2020 and confirmed by allergist. They will receive nasal spray for one month and they will asked about any sign or symptoms of viral infection during last year, and those with negative history will recruited. after production of nasal spray, pharmacist will use rand function of Excel app and randomized sprays, then numbered nasal sprays will use blindly. It will administered in first month of autumn, so virus exposure will be almost similar in school aged children. In next month they will asked about these parameters(with 2 weeks interval):
fever; new onset respiratory symptoms or exacerbation of preexisting symptoms; gastrointestinal presentations; taste or olfactory disorders.
Participants/Inclusion and exclusion criteria
Persistent asthma children aged between 6-18 years old; without history of COVID-19 infection, or any contraindications for probiotic
Intervention groups
Patients will receive one month, probiotic nasal spray- one puff in each nostril, two time per day- containing lactobacillus reuteri and lactobacillus casei
Investigation of probiotic nasal spray efficacy in prevention of COVID-19 and other common respiratory viruses in asthmatics children
Public title
Probiotic nasal spray in prevention of COVID-19 and other common respiratory viruses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Asthmatic children
Exclusion criteria:
Positive history of COVID-19
Autoimmunity
Malignancy
Complication after nasal spray use
Unwilling to continue participation in trial
Age
From 6 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: simple randomization; unit of randomization: individual; allocation concealment: closed envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
After preparation of nasal sprays, each of them will have a randomized code; then clinicians blindly administer them to patients in two groups of case and control. After data gathering, they will be analyzed blindly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Elm va Fanavari Shahrak, In the end of Shahid Fakouri Blvd. (In front of Fakouri 94)
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.MUMS.REC.1399.311
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Investigation of preventive effect of probiotic nasal spray in incidence of upper respiratory infection
Timepoint
Every two weeks until one month
Method of measurement
Checklist of signs and symptoms
2
Description
Axillary temperature above 38 Celsius degree
Timepoint
Every two weeks until one month
Method of measurement
Mercury thermometer placed in axillary space
3
Description
Exacerbation of Respiratory symptoms
Timepoint
Every two weeks until one month
Method of measurement
Checklist of symptoms
4
Description
Development of gasterointestinal symptoms
Timepoint
Every two weeks until one month
Method of measurement
Checklist of symptoms
5
Description
Abnormality in smell or gestatory senses
Timepoint
Every two weeks until one month
Method of measurement
Checklist of symptoms
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: probiotic nasal spray, which administer twice daily, one puff in each nostril, for one month. Lactobacillus reuteri and lactobacillus casei strains will cultured in 37 centigrade degree in 24 hours. then they will be centrifuged and with adding isotonic sodium chloride, 10 8 CFU/ ml concentration will be obtained. with appropriate ratio of glucose and fructose, we will enhance probiotic growth. after heating of solution, we culture it again and confirm obtaining heated and lysate probiotic nasal spray.
Category
Prevention
2
Description
Control group: rhinosalin nasal spray, which administer twice daily, one puff in each nostril, for one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar children's hospital
Full name of responsible person
Nasrin Moazzen
Street address
Kaveh street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 0871 3801
Fax
+98 51 3870 9201
Email
moazzenn@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research and technology office of Mashhad university of medical sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Shahrak Danesh va Salamat, Shahid Fakouri Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Fax
+98 51 3871 3638
Email
ramreaserch@mums.ac.ir
Grant name
Office of Research and Technology, mashhad university of medical sciences
Grant code / Reference number
990245
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research and technology office of Mashhad university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasrin Moazzen
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Akbar children' s hospital, shahid Kaveh Blvd, in front of No 14 Kaveh street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
moazzenn@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasrin Moazzen
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Akbar children's hospital, Kaveh street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
moazzenn@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasrin Moazzen
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Immunology
Street address
Akbar children's hospital, Kaveh street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3801
Email
moazzenn@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available