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

NCT ID: NCT02164344

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

HIV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Probiotics

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

Group Type: EXPERIMENTAL

probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Giancarlo Ceccarelli

MD, PhD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Vullo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rome "Sapienza" (Italy)

Locations

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

Countries

Italy

References

d'Ettorre G, Ceccarelli G, Giustini N, Serafino S, Calantone N, De Girolamo G, Bianchi L, Bellelli V, Ascoli-Bartoli T, Marcellini S, Turriziani O, Brenchley JM, Vullo V. Probiotics Reduce Inflammation in Antiretroviral Treated, HIV-Infected Individuals: Results of the "Probio-HIV" Clinical Trial. PLoS One. 2015 Sep 16;10(9):e0137200. doi: 10.1371/journal.pone.0137200. eCollection 2015.

Reference Type: DERIVED

PMID: 26376436 (View on PubMed)

Other Identifiers

DPHID-UniRoma03

Identifier Type: -

Identifier Source: org_study_id