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IRCT20181020041387N1 IRCT 2022-11-01 Shahid Beheshti University of Medical Sciences The effect of probiotics on CF The effect of Lactobacillus Reuteri on pulmonary function in Cystic Fibrosis 2021-10-17 anticipated 40 Complete https://irct.ir/trial/66090 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, patients are randomly divided into 2 groups: intervention group (as probiotic supplement group) and control group (as placebo group) (named groups A and B). Randomization is done by permuted block randomization method and concealment is done. Patients are divided into two groups using the above method. Six of the four combinations of intervention groups A and B are determined AABB ABAB ABBA BBAA BABA BAAB and randomly select each of the above combinations and those who agree to participate in the study are placed in study groups. It is also necessary to explain that in order to observe the concealment in the mentioned plan, the randomization operation is performed by a person other than the main researcher, Blinding description: In this study, the participant, the researcher doctor who provides the drug to the patient and is responsible for the follow-up of the patient, and the statistician, are blind to the groups. Medicines have two codes A or B. After the completion of the study and analysis by the statistician, the codes are determined by the manufacturing company. 3 Cystic Fibrosis. Intervention 1: Intervention group: Receiving standard treatment for cystic fibrosis plus one Lactobacilus reuterri sachet daily for 4 months. Intervention 2: Control group: Receiving standard treatment for cystic fibrosis plus one placebo sachet daily for 4 months. Yes - There is a plan to make this available What will be shared: Questionnaire information may be shared after completion of the study by removing the names and contact information of the patients. When: Twelve months To whom: Faculty members and students Conditions: Request through email Where to obtain: Email to dr.modarres@gmail.com How to obtain: Email to dr.modarres@gmail.com Comments:
public Seyedeh Zalfa Modaresi
Mofid's children hospital, shariati street,
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 dr.modarres@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyedeh Zalfa Modaresi
Mofid's children hospital, shariati street,
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 dr.modarres@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who have been diagnosed with CF based on clinical signs and sweat Chloride test. No pulmonary exacerbation two weeks prior the study. Ability to perform spirometry test. The informed willingness to participate in the study. Presence of no other chronic disorder except complications related to CF Six to Twenty years old patients with Cystic Fibrosis disease. The Forced Expiratory Volume in 1 second (FEV1) greater than 40%. Stable clinical condition and no acute upper and lower respiratory infection. 6 years 20 years Both Diagnosed as CF less than 6 months. New complication of CF during the past 3 months. No routine follow up. Disability to perform and repeat spirometry test according to American Thoracic Society criteria E84 Cystic fibrosis Treatment - Drugs Placebo Intervention group: Receiving standard treatment for cystic fibrosis plus one Lactobacilus reuterri sachet daily for 4 months. Control group: Receiving standard treatment for cystic fibrosis plus one placebo sachet daily for 4 months. Pulmonary exacerbation frequency. Timepoint: During study period (4 months). Method of measurement: Observing symptoms of exacerbation in follow-up visits or patient statements. Hospitalization frequency. Timepoint: During study period (4 months). Method of measurement: Patient statements. Weight Z-score. Timepoint: At baseline and at the end of study. Method of measurement: Scale. Height Z-score. Timepoint: At baseline and at the end of study. Method of measurement: Meter. BMI Z-score. Timepoint: At baseline and at the end of study. Method of measurement: Weight(kg)/ Height(m)2. FEV1 Forced Expiratory Volume in First Second. Timepoint: At baseline and at the end of study. Method of measurement: Spirometry. FEF25-75 Exhale middle airflow. Timepoint: At baseline and at the end of study. Method of measurement: Spirometry. FEV1/FVC proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full, forced vital capacity. Timepoint: At baseline and at the end of study. Method of measurement: Spirometry. Forced Vital Capacity (FVC). Timepoint: At baseline and at the end of study. Method of measurement: Spirometry. Shahid Beheshti University of Medical Sciences Approved 2021-10-12 Research ethics committees of school of medicine- Shahid Beheshti University of Medical Sciences Mofid's children hospital, Shariati street Tehran Tehran Iran (Islamic Republic of)