title: Probiotics Reduce Inflammation in Antiretroviral Treated, HIV-Infected Individuals: Results of the "Probio-HIV" Clinical Trial.
abstract: BACKGROUND
  HIV infection results in damage to the gastrointestinal (GI) tract, microbial translocation and immune activation. These are not completely normalized with combined antiretroviral therapy (cART). Moreover, increate morbidity and mortality of cART-treated HIV-infected individuals is associated with inflammation.
  
  
  METHODS
  In order to enhance GI tract immunity, we recruited and treated 20 HIV-infected humans with cART supplemented with probiotics and followed inflammation and immunological parameters (clinical trial number NCT02164344). 11 HIV seronegative subjects were included as control group. The enumeration of CD4+, CD8+, CD38+ and HLA-DR+ lymphocytes were evaluated on peripheral blood; HIV-RNA levels, sCD14, d-dimer, C-reactive protein (CRP) high sensitivity C-reactive protein (hsCRP), IL-6 and Lipopolysaccharide Binding Protein (LBP) were assayed on plasma.
  
  
  RESULTS
  We observe that cART does not normalize the levels of immune activation in HIV positive patients anyway inflammation and markers of microbial translocation were significantly reduced with probiotic supplementation. Patients show a clear and statistically significant reduction in the levels of immune activation on CD4 T-lymphocytes, for both markers CD38 and HLA-DR and their simultaneous expression, LBP and hsCRP plasma levels after probiotic diet supplementation settling to values comparable to controls.
  
  
  CONCLUSIONS
  Supplementing cART with probiotics in HIV-infected individuals may improve GI tract immunity and there by mitigate inflammatory sequelae, ultimately improving prognosis.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02164344.
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: d'Ettorre
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Ceccarelli
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Noemi
authors.initials: N
authors.lastname: Giustini
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Serafino
authors.affiliation: Program in Barrier Immunity and Repair, Lab of Molecular Microbiology, NIAID, NIH, Bethesda, Maryland, United States of America.
authors.forename: Nina
authors.initials: N
authors.lastname: Calantone
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Gabriella
authors.initials: G
authors.lastname: De Girolamo
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Bianchi
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Bellelli
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Ascoli-Bartoli
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Sonia
authors.initials: S
authors.lastname: Marcellini
authors.affiliation: Department of Virology, University of Rome "Sapienza", Rome, Italy.
authors.forename: Ombretta
authors.initials: O
authors.lastname: Turriziani
authors.affiliation: Program in Barrier Immunity and Repair, Lab of Molecular Microbiology, NIAID, NIH, Bethesda, Maryland, United States of America.
authors.forename: Jason M
authors.initials: JM
authors.lastname: Brenchley
authors.affiliation: Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Vullo
mesh_terms: D000328:Adult; D000368:Aged; D000375:Aging / Q000187:drug effects / Q000276:immunology; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D003131:Combined Modality Therapy; D064806:Dysbiosis / Q000150:complications; D005260:Female; D000069196:Gastrointestinal Microbiome / Q000187:drug effects; D015658:HIV Infections / Q000150:complications / Q000178:diet therapy* / Q000276:immunology / Q000382:microbiology*; D006801:Humans; D007249:Inflammation / Q000150:complications / Q000178:diet therapy; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents