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

Not Applicable

• Conditions: HIV
• Interventions: Dietary Supplement: probiotics

• Registration Number: NCT02164344
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-12
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-16
• Last Update Posted: 2014-06-16
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)	3 months	Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)

Secondary Outcome Measures

Name	Time	Method
Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+	3 months	Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)
CD4 recovery (ΔCD4)	3 months	CD4 recovery (ΔCD4),in blood at T0 and T1

Trial Locations

Locations (2)

Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy; 🇮🇹 Rome, RM, Italy

Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy); 🇮🇹 Rome, Italy