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IRCT20180425039412N1 IRCT 2019-03-10 Iran University of Medical Sciences Effect of probiotic in premenstrual syndrome Effect of synbiotic supplementation on reduction of severity of anxiety and depression in women with premenstrual syndrome 2018-09-23 anticipated 160 Complete https://irct.ir/trial/31555 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, the permuted block randomization will be used with quadruple blocks. According to the sample size of 160 identified, 40 blocks will be produced using the online site (www.sealedenvelope.com), Blinding description: In this study, producer provides supplements in two groups A and B and similar in appearance to the researcher without identifying the nature of the group.Then, the volunteers participating in the study by the statistician who do not know the type of effective substance in the groups are randomly divided into groups. The researcher, based on the list of counseling statisticians, distributes the supplements to them by explaining the study information and obtaining informed consent from the volunteers. 2-3 premenstrual syndrome. Intervention 1: 80 students and medical staff of Iran University of Medical Sciences receive synbiotic supplement with 10 microbial population to 9 colonies per gram, containing (Lactobacillus gassery, Lactobacillus officinalis, Lactobacillus plantarum, Lactobacillus acidophilus) daily 1 in 3 menstrual periods for 10 days before menstruation and 4 days after menstruation. Synbiotic supplement purchased from Zist takhmir company. Intervention 2: Control group: 80 female students and personnel of the University of Medical Sciences each day received 1 placebo capsule (containing lactose, magnesium stearate, talc, silicone dioxide) in 3 menstrual periods for 10 days before menstruation and 4 days after menstruation. The placebo capsule is similar to synbiotic supplementation. A supplement of placebo is purchased from Zist takhmir company. Yes - There is a plan to make this available What will be shared: The total individual participant data is shared When: Get started since 1398 To whom: researchers Conditions: Researcher if permission is granted Where to obtain: marjan malakooti nejad phone number 09123375596 How to obtain: After registering the title and publishing the article Comments:
public Dr Mitra Zarrati
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4814 zarrati.m@iums.ac.ir Iran University of Medical Sciences scientific Dr Mitra Zarrati
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4814 zarrati.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age range 18-40 years BMI Between 35 and 25 Affection of premenstrual syndrome based on PSST questionnaire The normal duration of bleeding (3-7 days in the 3 months before entering the study) and the regular monthly cycle Lack of chronic systemic diseases and diseases related to the ovary Lack of liver disease, bile duct disease, gastrointestinal and intestinal diseases, kidney disease, parathyroid thyroid and non-hyperphosphatemia Non-use of probiotic and probiotic-based supplements over the past 6 months Not using supplements containing vitamins and minerals supplement W3 or fish oil Non-development of neurological diseases and no use of psychosomatic drugs Non-use of hormonal drugs The desire to participate in the study and written consent written consent Absence of iron deficiency anemia Non-use of steroidal and non-steroidal anti-inflammatory drugs, Anti epileptic drugs, anti cholesterolemic drugs, anti-acid drugs, diuretics and laxatives Not using any medication or dietary supplement that affects weight 18 years 40 years Female Consumption of probiotic supplementation from 3 months before study Affection of acute and chronic diseases of depression Iron deficiency anemia Treatment - Drugs Placebo 80 students and medical staff of Iran University of Medical Sciences receive synbiotic supplement with 10 microbial population to 9 colonies per gram, containing (Lactobacillus gassery, Lactobacillus officinalis, Lactobacillus plantarum, Lactobacillus acidophilus) daily 1 in 3 menstrual periods for 10 days before menstruation and 4 days after menstruation. Synbiotic supplement purchased from Zist takhmir company. Control group: 80 female students and personnel of the University of Medical Sciences each day received 1 placebo capsule (containing lactose, magnesium stearate, talc, silicone dioxide) in 3 menstrual periods for 10 days before menstruation and 4 days after menstruation. The placebo capsule is similar to synbiotic supplementation. A supplement of placebo is purchased from Zist takhmir company. Depression. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: questionnaire. Anxiety. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: questionnaire Before intervention and 1.2 and 3 months after the intervention. BMI. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: Weight ratio (kg) to squared height (m). Waist circumference. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: meter. Nutritional status. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: Measurement of energy and nutrients intake using 24-hour dietary recall method and anthropometric measurement using scale and stadiometer. Physical Activity. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: IPAQ questionnaire. Quality of life. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: ququestionnaire. Fat percent. Timepoint: Before the intervention, 1.2 and 3 months after the intervention. Method of measurement: enbody. Zist takhmir company Approved 2018-04-21 Ethics committee Of Iran University Of Medical Sciences Iran University of Medical Sciences, next to the Milad hospital, the intersection Of sheikh Fazlallah and Shahid Chamran, Hemmat expressway tehran Tehran Iran (Islamic Republic of)