Effect of 1-year Antiretroviral Treatment on Gut Microbiota Diversity and Composition in Treatment-naïve HIV-infected Chinese Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Gut bacterial community diversity and composition
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-65 years old;
- •Documented HIV infection;
- •No history of gastrointestinal diseases;
- •Good adherence and promise to follow-up;
- •Ability to provide informed consent.
Exclusion Criteria
- •Administration of antibiotics, probiotics, or prebiotics or experience of diarrhea within the previous 3 months;
- •Administration of anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, immunomodulator within the previous 3 months;
- •Severe organ dysfunction;
- •Pregnancy or breastfeeding.
Arms & Interventions
All participants
All enrolled participants in this study
Intervention: Antiretroviral Therapy (Drug)
Outcomes
Primary Outcomes
Gut bacterial community diversity and composition
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
Secondary Outcomes
- Plasma levels of inflammation and coagulation markers(Change from baseline to 1 year after antiretroviral therapy)
- Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures(Change from baseline to 1 year after antiretroviral therapy)
- Absolute CD4+ T-cell and CD8+ T-cell counts in peripheral plasma(Change from baseline to 1 year after antiretroviral therapy)
- The level of T cell activation and different immunophenotype in peripheral plasma(Change from baseline to 1 year after antiretroviral therapy)
- Metabolic measurements from blood plasma(Change from baseline to 1 year after antiretroviral therapy)
- Plasma levels of microbial translocation and monocyte activation markers(Change from baseline to 1 year after antiretroviral therapy)
- HIV RNA(Change from baseline to 1 year after antiretroviral therapy)