Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy (PROBIO-HIV)

University of Roma La Sapienza

Status: Unknown

Conditions: HIV

Treatments: Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT02164344

DPHID-UniRoma03

Details and patient eligibility

About

Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation.

None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause.

In this longitudinal study we aim:

1. to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics.
2. to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status

Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HIV positive patients
• HIV viral load < 50 copies/ml
• antiretroviral therapy from at least 2 years

Exclusion criteria

• intestinal diseases
• opportunistic diseases
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Probiotics

Experimental group

Description:

HIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months

Treatment:

Dietary Supplement: probiotics