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Comparing the efficacy of probiotic and postbiotic supplements in patients with HIV in terms ofimproving symptoms of anxiety, depression, appetite, cognitive disorders, and sleep disorders, a three-blindrandomized clinical trial with placebo control.

Comparing the efficacy of probiotic and postbiotic supplements in patients with HIV in terms ofimproving symptoms of anxiety, depression, appetite, cognitive disorders, and sleep disorders, a three-blindrandomized clinical trial with placebo control.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220206053958N1
Enrollment
75
Registered
2025-07-07
Start date
2025-07-23
Completion date
Unknown
Last updated
2025-07-21

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: Probiotic intervention group treated with Lactobacillus acidophilus and Saccharomyces boulardii (twice a day with a dose of one capsule multiplied by 10 to the powe

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: HIV-infected patients who refer to the Shahid Sabzeh Parvar Center for outpatient treatment and whose immune system is in a balanced state and who are not hospitalized are referred to a psychiatrist by an infectious disease specialist. The individual's voluntary willingness to participate in the study Age 18 to 60 years IQ above 70 Absence of drugs and stimulants (in the context of a urine toxicology test for amphetamine and methamphetamine, all opioids, morphine, methadone, and marijuana are taken from the patient) and alcohol. Absence of other psychiatric disorders such as schizophrenia, bipolar disorder, depression with psychosis Not receiving electroshock in the last two weeks

Exclusion criteria

Exclusion criteria: Having a prominent neurological or organic disease and cardiovascular disease and a history of cardiac surgery or any cardiovascular procedure, clinically and laboratory tests and a review of the family history and records. Presence of another diagnosis on the axis according to DSM-V IQ less than 70 based on clinical suspicion Substance and alcohol abuse (except nicotine and caffeine) Oral antipsychotic use in the past week or long-acting antipsychotic use in the past month Received ECT in the past two weeks Women of childbearing age without adequate contraception will not be accepted. Hospitalized AIDS patients

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

zandifaratefe@gmail.com+98 26 3622 0118

Outcome results

None listed

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