To assess the effect of probiotic versus placebo on non-bacterial infections of the upper respiratory system in infants
Design
This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using a number generated by the computer.
Settings and conduct
This study will be conducted at the Besat Hospital in Hamadan city, involving 450 eligible infants with non-bacterial infections of the upper respiratory system. The patients will be randomly assigned to the intervention and control groups using a number generated by the computer. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Infants 6 to 12 months
Nonbacterial upper respiratory tract inflammation
Exclusion criteria:
Respiratory tract infection
Immune system defect
Intervention groups
Intervention group:
Routine treatment plus feeding 100 ml of pasteurized fermented milk containing LGG at a dose of 109 units through a milk bottle twice a day for one week
Control group:
Routine treatment plus feeding 100 ml of pasteurized fermented milk without LGG through a milk bottle twice a day for one week
Main outcome variables
Primary outcome:
Severity and duration of clinical signs and symptoms, duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N521
Registration date:2024-08-14, 1403/05/24
Registration timing:prospective
Last update:2024-08-14, 1403/05/24
Update count:0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-15, 1403/06/25
Expected recruitment end date
2024-11-19, 1403/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic versus placebo on non-bacterial infections of the upper respiratory system in infants: a double-blind randomized clinical trial
Public title
Effect of probiotic versus placebo on non-bacterial infections of the upper respiratory system in infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants 6 to 12 months
Nonbacterial upper respiratory tract inflammation
Exclusion criteria:
Respiratory tract infection
Immune system defect
Age
From 6 months old to 12 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
450
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups using computer generated numbers. For this purpose, we receive a number from the computer when each patient visits, if the number is odd, the patient will be assigned to the intervention group, and if the number is even, to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.UMSHA.REC.1402.560
Health conditions studied
1
Description of health condition studied
Non-bacterial infections of the upper respiratory system
ICD-10 code
J39.9
ICD-10 code description
Disease of upper respiratory tract, unspecified
Primary outcomes
1
Description
Severity and duration of clinical signs and symptoms of non-bacterial upper respiratory system infections
Timepoint
Before the intervention and one week later
Method of measurement
By taking history and clinical examination
2
Description
Duration of hospitalization
Timepoint
After the intervention
Method of measurement
By examining the patient's medical record
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus feeding 100 ml of pasteurized fermented milk containing LGG at a dose of 109 units through a milk bottle twice a day for one week
Category
Treatment - Drugs
2
Description
Control group: Routine treatment plus feeding 100 ml of pasteurized fermented milk without LGG through a milk bottle twice a day for one week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Amir Mohammad Khorsandi Nejad
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
amirkhorsandi1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Amir Mohammad Khorsandi Nejad
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
amirkhorsandi1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Shalchi
Position
Infectious Disease Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shalchi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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