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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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190316043072N3
Enrollment
50
Registered
2023-05-31
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

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

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Mild gastrointestinal discomfort. Timepoint: At the beginning of this study, 4th ,8th and 12th weeks. Method of measurement: Medical history.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtefe Zandifar

Karaj University of Medical Sciences

emamali@abzums.ac.ir+98 26 3250 0123

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026