The study will be performed on patients with asthma in Semnan province that visited by physician in university clinic. The simple randomization using cards shuffling will be done. Allocation concealment will be considered via sealed and opaque envelopes. Briefly, 20 envelopes contain probiotic supplement and another 20 envelopes have placebo with their own specific codes that will be prescribed using cards shuffling method. After probiotic supplement prescription and placeco during 60 days, laboratory and clinical variables will be concidered.
Participants/Inclusion and exclusion criteria
Inclusion criteria for participants includes all patients with asthma who have dry- or with slight sputum cough, wheezing, dyspnea sign and sometimes have the chest tightness or pain symptom and exclusion criteria includes patients who have lung infectious diseases such as pneumonia, coronary heart disease, lung cancer, primary and secondary immunodeficiency, and patients who smoke and take antibiotics.
Inclusion and exclusion criteria is same for both intervention and control groups.
Intervention groups
The intervention group includes patients who receive probiotic supplement and control group includes patients that receive placebo.
Main outcome variables
Outcomes related to intervenvention on patients will include cellular, molecular and clinical changes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191220045830N1
Registration date:2020-02-08, 1398/11/19
Registration timing:prospective
Last update:2020-02-08, 1398/11/19
Update count:0
Registration date
2020-02-08, 1398/11/19
Registrant information
Name
Sina Sadrifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 0532
Email address
sadrifarsina@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2022-03-17, 1400/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of probiotic supplement to improvement of signs and immunomodulation in patients with asthma
Public title
Evaluation of probiotic effect on asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with asthma who have dry- or with slight sputum cough sign.
All patients with asthma who have wheezing sign.
All patients with asthma who have dyspnea sign.
All patients with asthma who sometimes have the chest tightness or pain symptom.
Exclusion criteria:
The patients who have lung infectious diseases such as pneumonia.
The patients who have coronary heart disease.
The patients who have lung cancer.
The patients who have primary immunodeficiency.
The patients who have secondary munodeficiency such as HIV.
The patients who smoke.
The patients who take antibiotics.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization using cards shuffling will be performed. Briefly, 40 cards will be numbered and each card is representative of each envelope contain probiotic supplement or placebo.
Allocation concealment will be done via sealed and opaque envelopes. Briefly, 20 envelopes contain probiotic supplement and another 20 envelopes have placebo with their own specific codes that will be prescribed using cards shuffling method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of patients will be obtained by use of same shape capsules the contain either probiotic supplement or placebo.
Blinding of researcher and physician will be done using sealed and opaque envelopes.
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 and Health Services, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.SEMUMS.REC.1398.226
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Gene expression changes of T-bet, GATA3, Rorγt and FoxP3 transcription factors in peripheral blood mononuclear cells
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using real-time PCR method
2
Description
Frequency changes of Treg cells in peripheral blood
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using a flow cytometry
3
Description
Gene expression changes of miR 21, miR 155, miR146a, miR 126, miR 16 and miR133b in serum
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using real-time PCR method
4
Description
Changes in serum level of IL-4 and IFN-γ
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using ELISA method
5
Description
Gene expression changes of IL-6, IL-17, IL-21 and TGF-β in peripheral blood mononuclear cells
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using real-time PCR method
6
Description
Change rates of Forced Expiratory Volume in first second (FEV1)
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using Spirometery
7
Description
Change rates of Forced Vital Capacity (FVC)
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using Spirometery
8
Description
Change rates of Forced Expiratory Volume in first second (FEV1)/Forced Vital Capacity (FVC)
Timepoint
Before and 60 days after beginning of intervention
Method of measurement
Using Spirometery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive one probiotic supplement capsule include 1 billion colony forming unit (CFU) from Zisttakhmir company called Lactocare every day after the meal for 60 days.
Category
Treatment - Drugs
2
Description
Control group will receive one placebo capsule include starch from Zisttakhmir company every day after the meal for 60 days.
Semnan University of Medical Sciences and Health Services Headquarters., Basij Blvd
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3344 1022
Email
p_kokha@yahoo.com
Web page address
https://semums.ac.ir
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
Rasoul Baharlou
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology., Semnan University of Medical Sciences., Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 21 6526 4249
Email
baharlour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Rasoul Baharlou
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Department of Immunology., Semnan University of Medical Sciences., Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 21 6526 4249
Email
baharlour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sina Sadrifar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Immunology
Street address
Department of Immunology., Semnan University of Medical Sciences., Damghan Road., Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 21 6600 0532
Fax
+98 23 3344 8999
Email
sadrifarsina@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The clinical and laboratory data on patients with asthma that treated with drug and placebo can be shared
When the data will become available and for how long
6 month after result publication
To whom data/document is available
It will be accessible to university, scintific and production sections
Under which criteria data/document could be used
Data can be analysed and usable by clinical institutes
From where data/document is obtainable
Department of Internal Medicine, Kosar hospital, Semnan University of Medical Sciences
Department of Immunology, School of Medicine, Semnan University of Medical Sciences
1- Dr Rasoul Baharlou email: baharlour@gmail.com
2- Dr Farhad Malek email: farhadmalek42@yahoo.com
What processes are involved for a request to access data/document
The applicant can ask researchers to consider their request after article publication via formal letter- university or scientific institute and prodution section using email to recieve files