The effect of probiotics in improving symptoms of anxiety, depression and appetite in HIV positive patients

Phase 3

Conditions: Condition 1: Human immunodeficiency virus [HIV] disease. Condition 2: depressive disorder. Condition 3: Insomnia.
Human immunodeficiency virus [HIV] disease
Major depressive disorder, single episode
Insomnia not due to a substance or known physiological condition
F51.0

Registration Number: IRCT20190316043072N3

Lead Sponsor: Karaj University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures