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

HIV Clinical Trial

— PROBIO-HIV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02164344
• Other study ID #: DPHID-UniRoma03
• Status: Active, not recruiting
• Phase: N/A
• First received: June 11, 2014
• Last updated: June 12, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Dietary Supplement:
• probiotics
probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)	Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)	3 months	No
Secondary	Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+	Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)	3 months	No
Secondary	CD4 recovery (?CD4)	CD4 recovery (?CD4),in blood at T0 and T1	3 months	No