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IRCT20191220045830N1 IRCT 2020-02-08 Semnan University of Medical Sciences Evaluation of probiotic effect on asthma Evaluation of therapeutic effect of probiotic supplement to improvement of signs and immunomodulation in patients with asthma 2020-04-20 anticipated 40 Complete https://irct.ir/trial/44375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Asthma. Intervention 1: 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. Intervention 2: Control group will receive one placebo capsule include starch from Zisttakhmir company every day after the meal for 60 days. Yes - There is a plan to make this available What will be shared: The clinical and laboratory data on patients with asthma that treated with drug and placebo can be shared When: 6 month after result publication To whom: It will be accessible to university, scintific and production sections Conditions: Data can be analysed and usable by clinical institutes Where to obtain: 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 How to obtain: 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 Comments:
public Rasoul Baharlou
Department of Immunology., Semnan University of Medical Sciences., Damghan Road, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 21 6526 4249 baharlour@gmail.com Semnan University of Medical Sciences scientific Rasoul Baharlou‏
Department of Immunology., Semnan University of Medical Sciences., Damghan Road, Semnan
Semnan Iran (Islamic Republic of) 3514799442 +98 21 6526 4249 baharlour@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 65 years Both 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. J45 Asthma Treatment - Drugs Placebo 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. Control group will receive one placebo capsule include starch from Zisttakhmir company every day after the meal for 60 days. 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. Frequency changes of Treg cells in peripheral blood. Timepoint: Before and 60 days after beginning of intervention. Method of measurement: Using a flow cytometry. 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. 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. 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. Change rates of Forced Expiratory Volume in first second (FEV1). Timepoint: Before and 60 days after beginning of intervention. Method of measurement: Using Spirometery. Change rates of Forced Vital Capacity (FVC). Timepoint: Before and 60 days after beginning of intervention. Method of measurement: Using Spirometery. 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. Semnan University of Medical Sciences Approved 2019-12-17 Ethics committee of Semnan University of Medical Sciences Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)