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IRCT20090901002394N45 IRCT 2019-12-26 Iran University of Medical Sciences Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia 2019-11-11 anticipated 70 Complete https://irct.ir/trial/42762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Patients will be divided into two groups receiving two daily synbiotic capsules or placebo after coding using random codes. Random allocation will be performed using four blocks classified by BMI and gender, Blinding description: In order to double-blind the study of total cans containing capsules by a person other than the researcher, they will be divided into two groups in order to observe the researcher not knowing the type of capsules received by each group. Researcher, statistical consultant, and physician unaware of this classification This classification will be based on a random number table. 3 schizophrenia. Intervention 1: Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks. Intervention 2: Control group: Take 2 placebo capsules daily for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Poorya Basafaroodi
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 samanbasafa82@rocketmail.com Iran University of Medical Sciences scientific Dr Shima Jazayeri
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 sh_jazayeri@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Willingness to collaborate Complete the informed consent form by the patient and the patient's guardian Age range 18-65 years Schizophrenia according to DSM-V criteria (By a psychiatrist) Outpatient Duration of illness more than one year BMI ≥ 23 18 years 65 years Both Pregnancy and lactation A history of drug or alcohol dependence or abuse Diagnosis of mental retardation Diagnosis of neurological disease or any serious illness that needs treatment Diagnosis of major gastrointestinal, renal, heart, cancer, HIV infection or other immunodeficiency problems Having a history of traumatic brain injury, seizures, epilepsy, Loss of consciousness (LOC) for more than 30 minutes, or other known neurological or organic diseases of the central nervous system Having suicidal or homicidal thoughts or any safety concern by research staff Sensitivity to probiotics, prebiotic and synbiotic Subjects who may require imminent hospitalization Change the Dose and type of medication used during the last 2 months Receive of electricity shock treatment, immunosuppressive medications, stimulants, mood stabilizer during the last 3 months Receive of Antibiotics in the last month Consumption of Food or supplements containing probiotics, prebiotic and synbiotic over the last month such as kefir-yogurt-cheese and ... Consumption of dietary supplements in the last month Any disease or condition in which the researcher does not consider the participants appropriate for the study F20 Schizophrenia Treatment - Other Placebo Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks Control group: Take 2 placebo capsules daily for 8 weeks Waist circumference. Timepoint: 8 weeks. Method of measurement: Tape measure. Fasting blood sugar. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric. Total cholesterol. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric. HDL. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric. TG. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric. Blood pressure. Timepoint: 8 weeks. Method of measurement: Mercury barometer. LDL. Timepoint: 8 weeks. Method of measurement: Enzymatic colorimetric. Serum insulin. Timepoint: 8 weeks. Method of measurement: Eliza. HOMA-IR. Timepoint: 8 weeks. Method of measurement: Calculation by formula. QUICKI. Timepoint: 8 weeks. Method of measurement: Calculation by formula. HbA1c. Timepoint: 8 weeks. Method of measurement: analyzer. Hs-CRP. Timepoint: 8 weeks. Method of measurement: Eliza. Weight. Timepoint: 8 weeks. Method of measurement: Standard scales. BMI. Timepoint: 8 weeks. Method of measurement: Calculation measured by height and weight. Iran University of Medical Sciences Approved 2018-11-20 Ethics committee, Iran University of Medical Sciences Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)