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IRCT20220329054368N1 IRCT 2022-05-21 Yasouj University of Medical Sciences The effectiveness of probiotics on asthmatic patients The effectiveness of two types of probiotics (lactobacillusRhamnosus and Lactobacillus Reuteri ) on the pulmonary function test of moderate asthmatic patients aged 10 – 18 years. 2022-06-22 anticipated 120 Complete https://irct.ir/trial/62669 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: According to our knowledge, the present study is the first clinical trial study in Iran on the effect of probiotics in asthmatic patients, Randomization description: Randomization will be done in a random block method. The size of the blocks is chosen randomly (for example, blocks 4, 8, and 12) in which there is an equal number of each group in each block, Blinding description: Patients are unaware of their group and medications (drugs or placebo). 3 Asthma. Intervention 1: Intervention group 1: Lactobacillus rhamnosus probiotic group. The amount of 10 drops of this probiotic will be given daily and orally with the dropper. Intervention 2: Intervention group 2: Lactobacillus Rutri probiotic group. 5 drops will be given daily and orally. Intervention 3: Intervention group 3: Combination of Lactobacillus Rhamnosus and Lactobacillus Ruteri.10 drops of Lactobacillus Rhamnosus with 5 drops of Lactobacillus Ruteri will be given orally. Intervention 4: Control group: Placebo group.In glasses of the same color and similar to Lactobacillus Rhamnosus containing distilled water and orange essential oil, 10 drops will be given orally and daily. Yes - There is a plan to make this available What will be shared: Only data can be shared without patient names. When: 6 months after the publication of the article. To whom: Researchers Conditions: Sharing results to improve children's health. Where to obtain: FarnazSadat Javanmardi How to obtain: Formal request to be sent via email. Comments:
public Farnaz Sadat Javanmardi
Alley No. 8, Eram street
Shiraz Iran (Islamic Republic of) 7143838466 +98 71 3229 8671 farnaz.javanmardi@yums.ac.ir Yasouj University of Medical Sciences scientific Farnaz Sadat Javanmardi
Alley No. 8, Eram street
Shiraz Iran (Islamic Republic of) 7143838466 +98 71 3229 8671 farnaz.javanmardi@yums.ac.ir Yasouj University of Medical Sciences Iran (Islamic Republic of) Patients between 10 - 18 years A well-known case of persistent moderate asthma that has just been diagnosed and, has a medical record and approval from an asthma and allergy specialist. All patients are taking fluticasone spray. Have no history of other respiratory illnesses including interstitial pneumonia, cystic fibrosis, sickle cell disease, and primary ciliary dyskinesia 10 years 18 years Both Immigration or death of the patient. Patient dissatisfaction in continuing the treatment. In case of other infectious or chronic diseases during the research period. J45.3 Mild persistent asthma Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Lactobacillus rhamnosus probiotic group. The amount of 10 drops of this probiotic will be given daily and orally with the dropper. Intervention group 2: Lactobacillus Rutri probiotic group. 5 drops will be given daily and orally. Intervention group 3: Combination of Lactobacillus Rhamnosus and Lactobacillus Ruteri.10 drops of Lactobacillus Rhamnosus with 5 drops of Lactobacillus Ruteri will be given orally. Control group: Placebo group.In glasses of the same color and similar to Lactobacillus Rhamnosus containing distilled water and orange essential oil, 10 drops will be given orally and daily. Degree of asthma control, interleukin 13, blood eosinophil percentage, forced expiratory volume, peak expiratory flow, forced vital capacity. Timepoint: At the beginning of the study and two months after the intervention. Method of measurement: Asthma control test(ACT), spirometry, CBC diff, IL13 human kit. Faradaru company Approved 2022-03-30 Ethics committee of Yasuj University of Medical Science Eram Street, Alley NO.8 Shiraz Fars Iran (Islamic Republic of)