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IRCT20200117046164N2 IRCT 2021-09-24 research and technology office of Mashhad university of medical sciences Probiotic nasal spray in prevention of COVID-19 and other common respiratory viruses Investigation of probiotic nasal spray efficacy in prevention of COVID-19 and other common respiratory viruses in asthmatics children 2021-09-23 anticipated 90 Complete https://irct.ir/trial/52917 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization: simple randomization; unit of randomization: individual; allocation concealment: closed envelope, 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. 3 Asthma. Intervention 1: 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. Intervention 2: Control group: rhinosalin nasal spray, which administer twice daily, one puff in each nostril, for one month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Nasrin Moazzen
Akbar children' s hospital, shahid Kaveh Blvd, in front of No 14 Kaveh street
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 moazzenn@mums.ac.ir Mashhad University of Medical Sciences scientific Nasrin Moazzen
Akbar children's hospital, Kaveh street
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 moazzenn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Asthmatic children 6 years 18 years Both Positive history of COVID-19 Autoimmunity Malignancy Complication after nasal spray use Unwilling to continue participation in trial J45 Asthma Prevention Placebo 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. Control group: rhinosalin nasal spray, which administer twice daily, one puff in each nostril, for one month. 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. Axillary temperature above 38 Celsius degree. Timepoint: Every two weeks until one month. Method of measurement: Mercury thermometer placed in axillary space. Exacerbation of Respiratory symptoms. Timepoint: Every two weeks until one month. Method of measurement: Checklist of symptoms. Development of gasterointestinal symptoms. Timepoint: Every two weeks until one month. Method of measurement: Checklist of symptoms. Abnormality in smell or gestatory senses. Timepoint: Every two weeks until one month. Method of measurement: Checklist of symptoms. research and technology office of Mashhad university of medical sciences Approved 2020-11-21 Ethics committee of Mashhad University of Medical Sciences Elm va Fanavari Shahrak, In the end of Shahid Fakouri Blvd. (In front of Fakouri 94) Mashhad Razavi Khorasan Iran (Islamic Republic of)