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IRCT20190316043072N3 IRCT 2023-05-31 Karaj University of Medical Sciences The effect of probiotics in improving symptoms of anxiety, depression and appetite in HIV positive patients Investigating the effect of probiotic supplementation in improving symptoms of depression, anxiety, insomnia, anorexia and cognitive impairment in HIV-positive patients, a three-blind randomized clinical trial with placebo control. 2023-04-30 anticipated 50 Complete https://irct.ir/trial/69639 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the eligibility of the patient is recognized and written informed consent is received, the patients will be assigned to one of two intervention and comparison (placebo) groups by block randomization method with unequal block sizes of 2, 4, and 6. Prepare a randomization list becomes To prepare the randomization list, from the web-based software to the address https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used. Allocation concealment In order to hide the allocation, the sequence of allocation will be hidden by choosing the size of non-matching blocks. Also, the specific group of each patient will be placed in envelopes and the number of the envelope will match the order of sequence and the order of identification of the patient. At the time of identification of each patient, one of these envelopes will be opened, Blinding description: A placebo will be used to blind the patient. In this way, materials similar to probiotics in terms of color, taste, shape, and size are sold with the help of the pharmaceutical company. The researcher investigating the outcome and analyzing the data: He is not aware of the patient's random allocation group, and only the researcher who has the random list is aware of this issue. 3 Condition 1: Human immunodeficiency virus [HIV] disease. Condition 2: depressive disorder. Condition 3: Insomnia. Intervention 1: Intervention group: lactobacillus acidophilus capsule twice per day 10 exponent 8 unit daily for 12 weeks. Intervention 2: Control group: Starch placebo tablets exactly the same with probiotic capsules for 12 weeks. Yes - There is a plan to make this available What will be shared: We are going to share required data When: available on March 2023 To whom: Public article Conditions: Unconditional Where to obtain: Publisher journal or please sent massage to ah.hajialigol@gmail.com How to obtain: sent massage to ah.hajialigol@gmail.com Comments:
public Atefe Zandifar
Imam Ali hospital, beginning of Kaj blvd., Karaj
karaj Iran (Islamic Republic of) 3198764653 +98 26 3250 0123 emamali@abzums.ac.ir Karaj University of Medical Sciences scientific Atefe Zandifar
Imam Ali hospital, beginning of Kaj blvd., Karaj
karaj Iran (Islamic Republic of) 3198764653 +98 26 3250 0123 emamali@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Over 18 years of age IQ above 70 No consumption of alcohol, drugs and stimulants in the last three months based on the result of the urine test CD4 level above 350 in the last three months HIV-positive patients are outpatients and not hospitalized and in controlled physical conditions with the approval of an infectious disease specialist Voluntary willingness of the individual to participate in the plan 18 years no limit Both prominent neurological or organic disease and cardiovascular disease and history of cardiac surgery or any cardiovascular procedure clinical and laboratory examinations and family history Another diagnosis in Axis I based on DSM-V abusing of other substances (except nicotine and caffeine) taking oral antipsychotics in the past week or long-acting antipsychotics in the past month receiving ECT in the last two weeks women of childbearing age will not be accepted without adequate methods of contraception CHF and liver disease B20 F32 F51.0 Human immunodeficiency virus [HIV] disease Major depressive disorder, single episode Insomnia not due to a substance or known physiological condition Treatment - Drugs Placebo Intervention group: lactobacillus acidophilus capsule twice per day 10 exponent 8 unit daily for 12 weeks Control group: Starch placebo tablets exactly the same with probiotic capsules for 12 weeks Anxiety. Timepoint: At the beginning of the study, 4th ,8th ,and 12th weeks. Method of measurement: The Beck Anxiety Inventory (BAI). Anorexia. Timepoint: At the beginning of the study, 4th ,8th ,and 12th weeks. Method of measurement: Simple appetite questionnaire. Sleep quality. Timepoint: At the beginning of the study, 4th ,8th ,and 12th weeks. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Cognitive impairment. Timepoint: At the beginning of the study, 4th ,8th ,and 12th weeks. Method of measurement: Montreal cognitive assessment(MoCA). Mild gastrointestinal discomfort. Timepoint: At the beginning of this study, 4th ,8th and 12th weeks. Method of measurement: Medical history. Karaj University of Medical Sciences Approved 2023-04-17 Ethics committee of Alborz University of Medical Sciences Ethics Committee Office, 2nd floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Gol-shahr Karaj Alborz Iran (Islamic Republic of)