A study on therapeutic and anti-inflammatory effects of Saccharomyces cerevisiae boulardii probiotic in asthmatic patients referred to kowsar semnan hospital
A study on therapeutic and anti-inflammatory effects of Saccharomyces cerevisiae boulardii probiotic in asthmatic patients referred to kowsar semnan hospital
Design
Clinical trial with parallel control group, double blind, randomized, Control with placebo, single center trial, Sample size 60 people.
Settings and conduct
Semnan Kowsar Hospital.
250 mg of probiotic capsules under the brand name daily yeast for 3 month, 1 to 2 times a day.
The participant, the main researcher, health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type of medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Up to 60 years of age; Asthma confirmed by a pulmonologist.
Exclusion criteria: Kidney failure; Acute or chronic infection; Cancer.
Intervention groups
Intervention group: In addition to routine asthma treatments; 250 mg of probiotic capsules under the brand name daily yeast for 3 month, 1 to 2 times a day. Before and after the intervention, 7 cc of blood is taken to check for factors such as CRP, peripheral blood eosinophil counts, and IL5. Spirometry is performed before and after intervention for all individuals.
Control group: Patients are routinely treated for asthma according to the protocol. Only for comparison with intervention group.
Main outcome variables
Interleukin-5 (IL-5); Eosinophils.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N54
Registration date:2020-05-27, 1399/03/07
Registration timing:registered_while_recruiting
Last update:2020-05-27, 1399/03/07
Update count:0
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-21, 1399/02/02
Expected recruitment end date
2020-10-23, 1399/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on therapeutic and anti-inflammatory effects of Saccharomyces cerevisiae boulardii probiotic in asthmatic patients referred to kowsar semnan hospital
Public title
A study on therapeutic and anti-inflammatory effects of probiotic in asthmatic patients referred to kowsar semnan hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Up to 60 years of age
Asthma confirmed by a pulmonologist
Exclusion criteria:
Kidney failure
Acute or chronic infection
Cancer
Age
To 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 2).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the main researcher, health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.SEMUMS.REC.1399.021
Health conditions studied
1
Description of health condition studied
Asthmatic
ICD-10 code
J45.22
ICD-10 code description
Mild intermittent asthma with status asthmaticus
Primary outcomes
1
Description
Interleukin-5 (IL-5)
Timepoint
Before and after intervention
Method of measurement
ELISA
2
Description
Eosinophils
Timepoint
Before and after intervention
Method of measurement
Cell count by examining peripheral blood smears
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine asthma treatments; 250 mg of probiotic capsules under the brand name daily yeast for 3 month, 1 to 2 times a day. Before and after the intervention, 7 cc of blood is taken to check for factors such as CRP, peripheral blood eosinophil counts, and IL5. Spirometry is performed before and after intervention for all individuals.
Category
Treatment - Drugs
2
Description
Control group: Patients are routinely treated for asthma according to the protocol. Only for comparison with intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Bahador Bagheri
Street address
Street Amin, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
fatemehehsani59@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Bahador Bagheri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
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