NCT01258556已完成2 期
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Vaginal microbiota of HIV patients.
研究概览
简要总结
Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV infection;
- •Being treated with anti-retroviral medication for > 6 months.
排除标准
- •Pregnancy;
- •Hypersensitive to fermented milk;
- •Intolerant for lactose;
- •Complaints of bacterial vaginosis requiring treatment
研究组 & 干预措施
Probiotic yogurt
Experimental
干预措施: Yogurt supplemented with L. rhamnosus fiti (Dietary Supplement)
Placebo yogurt.
Placebo Comparator
干预措施: Yogurt not supplemented with a probiotic strain. (Dietary Supplement)
结局指标
主要结局
Vaginal microbiota of HIV patients.
时间窗: 30 days
次要结局
- Bacterial vaginosis.(30 days)
研究者
研究点 (1)
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