title: Randomized pilot trial of a synbiotic dietary supplement in chronic HIV-1 infection.
abstract: BACKGROUND
  Infection with HIV-1 results in marked immunologic insults and structural damage to the intestinal mucosa, including compromised barrier function. While the development of highly active antiretroviral therapy (HAART) has been a major advancement in the treatment of HIV-1 infection, the need for novel complementary interventions to help restore intestinal structural and functional integrity remains unmet. Known properties of pre-, pro-, and synbiotics suggest that they may be useful tools in achieving this goal.
  
  
  METHODS
  This was a 4-week parallel, placebo-controlled, randomized pilot trial in HIV-infected women on antiretroviral therapy. A synbiotic formulation (Synbiotic 2000®) containing 4 strains of probiotic bacteria (10(10) each) plus 4 nondigestible, fermentable dietary fibers (2.5 g each) was provided each day, versus a fiber-only placebo formulation. The primary outcome was bacterial translocation. Secondary outcomes included the levels of supplemented bacteria in stool, the activation phenotype of peripheral T-cells and monocytes, and plasma levels of C-reactive protein and soluble CD14.
  
  
  RESULTS
  Microbial translocation, as measured by plasma bacterial 16S ribosomal DNA concentration, was not altered by synbiotic treatment. In contrast, the synbiotic formulation resulted in significantly elevated levels of supplemented probiotic bacterial strains in stool, including L. plantarum and P. pentosaceus, with the colonization of these two species being positively correlated with each other. T-cell activation phenotype of peripheral blood lymphocytes showed modest changes in response to synbiotic exposure, with HLA-DR expression slightly elevated on a minor population of CD4+ T-cells which lack expression of HLA-DR or PD-1. In addition, CD38 expression on CD8+ T-cells was slightly lower in the fiber-only group. Plasma levels of soluble CD14 and C-reactive protein were unaffected by synbiotic treatment in this study.
  
  
  CONCLUSIONS
  Synbiotic treatment for 4 weeks can successfully augment the levels of probiotic species in the gut during chronic HIV-1 infection. Associated changes in microbial translocation appear to be absent, and markers of systemic immune activation appear largely unchanged. These findings may help inform future studies aimed at testing pre- and probiotic approaches to improve gut function and mucosal immunity in chronic HIV-1 infection.
  
  
  BACKGROUND
  Clinical Trials.gov: NCT00688311.
authors: Department of Medical Microbiology and Immunology, University of California, Davis, CA, USA.
authors: Marco
authors: M
authors: Schunter
authors: Hiutung
authors: H
authors: Chu
authors: Timothy L
authors: TL
authors: Hayes
authors: Delandy
authors: D
authors: McConnell
authors: Sean S
authors: SS
authors: Crawford
authors: Paul A
authors: PA
authors: Luciw
authors: Stig
authors: S
authors: Bengmark
authors: David M
authors: DM
authors: Asmuth
authors: Jennifer
authors: J
authors: Brown
authors: Charles L
authors: CL
authors: Bevins
authors: Barbara L
authors: BL
authors: Shacklett
authors: J William
authors: JW
authors: Critchfield
mesh_terms: D051997:ADP-ribosyl Cyclase 1 / Q000378:metabolism; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D001419:Bacteria / Q000235:genetics / Q000254:growth & development*; D018988:Bacterial Translocation; D002097:C-Reactive Protein / Q000378:metabolism; D015496:CD4-Positive T-Lymphocytes / Q000378:metabolism; D018414:CD8-Positive T-Lymphocytes / Q000378:metabolism; D002908:Chronic Disease; D003106:Colon / Q000276:immunology / Q000382:microbiology*; D004043:Dietary Fiber; D005243:Feces / Q000382:microbiology; D005260:Female; D005285:Fermentation; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism / Q000382:microbiology; D015497:HIV-1; D006684:HLA-DR Antigens / Q000378:metabolism; D006801:Humans; D007413:Intestinal Mucosa / Q000276:immunology / Q000382:microbiology*; D018950:Lipopolysaccharide Receptors / Q000097:blood; D008213:Lymphocyte Activation; D008297:Male; D008875:Middle Aged; D010641:Phenotype; D010865:Pilot Projects; D056692:Prebiotics; D019936:Probiotics; D061026:Programmed Cell Death 1 Receptor / Q000378:metabolism; D012336:RNA, Ribosomal, 16S / Q000097:blood / Q000235:genetics; D058616:Synbiotics
chemical_list: D019380:Anti-HIV Agents; D004043:Dietary Fiber; D006684:HLA-DR Antigens; D018950:Lipopolysaccharide Receptors; C105992:PDCD1 protein, human; D056692:Prebiotics; D061026:Programmed Cell Death 1 Receptor; D012336:RNA, Ribosomal, 16S; D002097:C-Reactive Protein; D051997:ADP-ribosyl Cyclase 1