]>
IRCT20090901002394N46 IRCT 2019-12-27 Iran University of Medical Sciences Effect of Synbiotic Supplementation on schizophrenia symptoms Effect of Synbiotic Supplementation on Symptoms and Brain-derived neurotrophic factor (BDNF) in patients with Schizophrenia 2019-11-27 anticipated 70 Complete https://irct.ir/trial/41832 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: Subjects will be divided into intervention and placebo groups by stratified randomization based on sex and BMI using 4-sided permutation blocks and randomly selected blocks based on random number table, Blinding description: Placebo and supplements are similar in appearance And someone other than the researcher encodes them. All investigators, study staff, and participants will be unaware of the allocations. 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 Somayeh Jamali paghaleh
Hemmat Highway, between the intersection of Sheikh Fazlollah noori and Chamran, next to the Milad Hospital, Iran University of Medical Sciences
tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 ccssoommaa@gmail.com Iran University of Medical Sciences scientific Dr shima jazayeri
school of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
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) Patients with PANSS total score ≥ 50 Outpatient Duration of illness less than 6 years 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 major gastrointestinal, renal, heart, cancer, HIV infection ,neurological disease or other immunodeficiency problems Having suicidal or homicidal thoughts Sensitivity to probiotics, prebiotic and synbiotic Change the Dose and type of medication used during the last 2 months Receive of Antibiotics in the last month Consumption of probiotics, prebiotic or synbiotic over the last month Consumption of dietary supplements in the last month F20-F29 Schizophrenia Treatment - Other Placebo Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks Control group: Take 2 placebo capsules daily for 8 weeks Symptoms of schizophrenia. Timepoint: at baseline, and after 2 month. Method of measurement: PANSS scale. Brain-derived neurotrophic factor. Timepoint: at baseline, and after 2 month. Method of measurement: Eliza. Anxiety and Depression Function. Timepoint: at baseline, and after 2 month. Method of measurement: Hospital Anxiety and Depression Scale. Gastrointestinal symptoms. Timepoint: at baseline, and after 2 month. Method of measurement: GSRS Scale. Physical activity. Timepoint: beginning and end of intervention. Method of measurement: IPAQ questionnaire. Energy intake. Timepoint: beginning and end of intervention. Method of measurement: 24-hour food recall questionnaire. Iran University of Medical Sciences Approved 2019-10-02 Ethics committee, Iran University of Medical Sciences Shahid Hemmat Highway, next to Milad Hospital, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)