Clinical Trial, Randomized and Controlled With Placebo to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic, Only or in Conjunction of a Pre-biotical, in Adults Infected by Hiv-1 With a cd4 Record Less Than 500 Cells / mm3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- The appearance of adverse effects.
研究概览
简要总结
The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).
详细描述
It's been demonstrated that the HIV-1 virus is associated to the reduction of the microbiota. Some studies suggest that because of this bacterial reduction, the premature aging appears. So this study aims to demonstrate that our probiotic can balance the microbiota as a preventive solution for the inflammaging.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 18 years old.
- •Documented HIV-1 infection.
- •Be in treatment with these antiretrovirals (INI, IP, ITINAN) during 12 months.
- •HIV-1 Viral titer <50 copies/mL during 6 months.
- •CD4> 500 cells/mm3.
排除标准
- •Treatment with antibiotics.
- •Severe diseases actives.
- •Defining diseases of AIDS in the previous year.
- •Gut surgery except appendectomy or cholecystectomy.
- •Pregnancy.
- •Any diet deviation (vegans).
- •Other probiotic treatment.
研究组 & 干预措施
i3.1 + ProSeed
This group will have their habitual antiretroviral therapy combined with the probiotic (i3.1) and the prebiotic (ProSheed). The prebiotic and probiotic will be taken once a day during 6 months.
干预措施: Prebiotic (Dietary Supplement)
Placebo
This group will only have their habitual antiretroviral therapy. The placebo will be taken once a day during 6 months.
干预措施: Placebo (Dietary Supplement)
i3.1 + ProSeed
This group will have their habitual antiretroviral therapy combined with the probiotic (i3.1) and the prebiotic (ProSheed). The prebiotic and probiotic will be taken once a day during 6 months.
干预措施: Probiotic (Dietary Supplement)
i3.1
This group will have their habitual antiretroviral therapy (integrase inhibitor (INI), protease inhibitor (IP), reverse transcriptase inhibitor (ITINAN)) combined with the research product (probiotic i3.1). The prebiotic will be taken once a day during 6 months.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
The appearance of adverse effects.
时间窗: Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).
Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo.
次要结局
- Gut microbiota diversity and metabolomic profile(A measure will be made in V1, V2, V3 and V4 (1 month, 3 months, 6 months and 9 months after the treatment beginning, respectively).)
- CD4/CD8 ratio(A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).)
- Satisfaction with the product(A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).)
- Questionaire to evaluate the life quality(A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).)
- Questionaires to evaluate the anxiety and depression(A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).)
- Translocational bacterial markers & Systemic inflammation markers(A measure will be made in V1 and V2 (1 month and 3 months after the treatment beginning, respectively).)
- Cluster of Differentation 4 (CD4) count(A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).)