Peking Union Medical College Hospital
Beijing, 100730, China
NCT Number: NCT04297501
HIV infection leads to destruction of CD4+T cells in the gut-associated lymphoid tissue (GALT) and promotes a decline in mechanical barrier functions of the gut mucosa, and the subsequent translocation of microbial products from the gastrointestinal tract to systemic circulation. The gut mucosal immune system is not completely restored by cART, and the resultant microbial translocation may contribute to chronic inflammation, inadequate CD4 T-cell recovery, and increased rates of serious non-AIDS events. Many studies have revealed strong and characteristic compositional differences in gut microbiota between individuals with HIV infection and seronegative controls. So far, several probiotic organisms have shown the ability to enhance intestinal epithelial barrier functions, reduce inflammation, and support effective Th-1 responses. Probiotics mainly stimulates polymeric IgA secretion, avoid bacterial overgrowth and their translocation, and produce a self-limited inflammatory response through development of regulatory T (Treg) cells by anti-inflammatory cytokine production. Therefore, we design a prospective, randomized, double-blind, placebo-controlled study to determine whether the use of a probiotic can expand beneficial microbiota that aid in decreasing bacterial translocation and pro-inflammatory cytokine production, thereby improving immune functions in HIV-infected subjects. Participants in the intervention group will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily, while those in the placebo group will take placebo which contains no probiotic but has the same flavor and characteristics as the probiotic product.. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 12 months of receiving intervention will be analyzed.
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Notify Me18 year–65 year
All sexes
Observational
Beijing, 100730, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count.
Time frame: Change from baseline to 1 year after antiretroviral therapy
Microbiota profiling are performed on fecal samples from each subjects, and 8-10 participants receive gastrointestinal endoscope according to their willingness
Time frame: Change from baseline to 1 year after antiretroviral therapy
CD4+ and CD8+ T cells are analyzed by flow cytometry
Time frame: Change from baseline to 1 year after antiretroviral therapy
CD38+HLA-DR+, CD8+CD28+ T cell subsets are analyzed by flow cytometry
Time frame: Change from baseline to 1 year after antiretroviral therapy
Levels of IL-8, IL-1β, IL-6, CRP, TNF-α and D-dimer
Time frame: Change from baseline to 1 year after antiretroviral therapy
Levels of I-FABP, LPS, LBP, sCD14, sCD40L, and IDO
Time frame: Change from baseline to 1 year after antiretroviral therapy
Levels of vitamin D, glucose and insulin, and lipid profiling
Time frame: Change from baseline to 1 year after antiretroviral therapy
Based on patients' description and intervention-related adverse events
Time frame: Change from baseline to 1 year after antiretroviral therapy
HIV-RNA is detected by Roche assay with the limit of 20 copies/mL
Peking Union Medical College Hospital
Other
Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals
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