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IRCT20090901002394N39 IRCT 2018-10-26 Iran University of Medical Sciences Effects of probiotic in generalized anxiety disorder Effect of probiotics on BDNF, neuropeptide y plasma and serum HS-CRP in patients with generalized anxiety disorder 2017-05-05 anticipated 48 Complete https://irct.ir/trial/31833 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects divided into two groups: intervention and placebo (stratified randomization)Based on age(18-40 40-65) Use 4-way permutation blocks and select blocks based on random numbers, Blinding description: Probiotic and placebo supplementation is similar in all respects and is encoded by a third person not aware of the contents of the cans and randomly divided into two groups of patients. None of the patients and the investigator will be aware of the group in which the patients are located. 3 Generalized anxiety disorde. Intervention 1: Intervention group: sertraline plus probiotic supplement Contain Bifidobacterium Longom, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus(18×109 CFU) and small amounts of fructooligosaccharides (a contributor to the growth and activity of microorganisms) daily after lunch for 8 weeks. Intervention 2: Control group: sertraline plus placebo capsule contains 220 mg starch, daily, after lunch 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 Mahnaz Reisian
School of public health, Iran university of medical sciences, Hemmat Highway,Tehran, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 Reisian2012@gmail.com Iran University of Medical Sciences scientific 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 jazayeri.sh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) DSM-V diagnosed of GAD Adults between 18 and 65 years old Willing to participate. 18 years 65 years Both Having illness including liver disease and kidney disease, diabetes, immune deficiency, etc Having psychological illnesses including psychosis, Suicidal ideation, bipolar disorder and major depression People who are expected to have limited partnerships such as forgetfulness and pregnancy Taking any medication in the previous 1 month Taking any medication related to psychiatric diseases including antidepressants, antipsychotics, etc. (maximum of two times per week) and antibiotics in the previous 1 month Taking any supplement including probiotic supplement, fiber, prebiotics, omega-3, vitamins and minerals in the previous 1 month; Consumption of fermented foods (except yogurt), such as sour cream, acidophilus milk, kefir and some cheeses such as blue vein cheese or Swiss cheese in the previous 1 month substance abuse The compliance less than 80%. F41.1 Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is "free-floating"). The dominant symptoms are variable but include complaints of persistent nervousne Treatment - Drugs Treatment - Drugs Intervention group: sertraline plus probiotic supplement Contain Bifidobacterium Longom, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus(18×109 CFU) and small amounts of fructooligosaccharides (a contributor to the growth and activity of microorganisms) daily after lunch for 8 weeks Control group: sertraline plus placebo capsule contains 220 mg starch, daily, after lunch for 8 weeks BDNF. Timepoint: At baseline, after 2 month. Method of measurement: Blood test. Hs-crp. Timepoint: At baseline, after 2 month. Method of measurement: Blood test. Neuropeptide y. Timepoint: At baseline, after 2 month. Method of measurement: Blood test. Iran University of Medical Sciences Approved 2017-05-03 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences,Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)