Effect and Safety of Probiotic Supplementation in Immune Non-responders With HIV-1 Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Immune recovery and activation
研究概览
简要总结
Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma/mucosa, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 6 months of receiving intervention will be analyzed.
详细描述
Up to 25% of HIV-infected individuals receiving antiretroviral treatment demonstrate suboptimal blood cluster of differentiation 4（CD4） recovery despite effective viral suppression; this "immunologic non-responder" (INR) phenotype is associated with increased immune activation and with higher rates of AIDS and non-AIDS related conditions, and death. Poor gut integrity, increased microbial translocation, and reduced CD4 T-cell trafficking to the gut could be a source of ongoing inflammation in INR individuals. Researches have shown that the gut microbiota compositions are different in INRs and immunological responders (IRs). Probiotics, by modulation of gut microbiota, can help induce epithelial healing and prevent bacterial translocation. Probiotic supplementation, therefore, may be a nutritional target for INRs by boosting CD4 cell counts. We design a prospective, case-control, self-contrast study to explore the efficacy and safety of probiotic supplementation in INRs. Participants will receive oral probiotic containing 3 billion Bifidobacterium and 1 billion Lactobacillus once daily. Gut bacterial community diversity and composition, immune recovery and activation in peripheral plasma/mucosa, plasma levels of gut damage, microbial translocation and inflammation at baseline and after 6 months of receiving intervention will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented HIV-1 infection
- •18-65 years old
- •On antiretroviral therapy (>2 years)
- •Ability to provide informed consent
- •Undetectable plasma HIV-1 viral load for the past 2 years
- •CD4 T-cell count <350/mm3 for the last 2 years
- •No history of gastrointestinal diseases
排除标准
- •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
结局指标
主要结局
Immune recovery and activation
时间窗: Changes from baseline to 6 months
CD4+ T-cell and cluster of differentiation 8（CD8）+ T-cell counts, CD4/CD8 ratio, cluster of differentiation 38（CD38）+/ human leukocyte antigen(HLA）-HLA class II(DR)+ CD8+/CD4+ T cell ratio
次要结局
- Plasma levels of gut damage, microbial translocation and inflammation(Changes from baseline to 6 months)
- Blood viral load(Changes from baseline to 6 months)
- Metabolic measurements from blood plasma(Changes from baseline to 6 months)
- Feasibility, safety, tolerability, adherence, and acceptability of study product and procedures(Changes from baseline to 6 months)
- Gut bacterial community diversity and composition(Changes from baseline to 6 months)