Developing Interventions for Protecting HIV-Exposed Uninfected Infants Against Severe Infections
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Infant gut microbiome
研究概览
简要总结
Research has shown that babies who are exposed to HIV, but are uninfected (negative HIV status), have a bigger risk of developing severe infections. There are naturally occurring organisms in the gut that may determine how the body protects itself against infections. These organisms may be different in babies who were exposed to the HIV virus in utero, compared to those who were not exposed. This study wants to see if the organisms in the gut of babies can be modified by supplementing the diet of the pregnant mother or of the baby at 6 months of age with Inkomasi (pasteurized fermented milk). The study will compare the type and amount of organisms in those who received supplementation and those who did not receive supplementation.
详细描述
- The study will enroll 24 pregnant women with HIV at 36 weeks gestational age and randomize them 1:1 to receive 500 ml daily of pasteurized fermented milk (Inkomasi) or not. Changes in maternal gut microbiota from enrollment to 2-4 weeks postpartum will be compared between groups. The study will also compare the gut microbiome at infants born to mothers who received Inkomasi with those born to mothers who did not receive Inkomasi.
- The study will enroll 24 HIV-exposed uninfected infants (HEU) at 24 weeks of age and randomize them 1:1 to receive ≥15 ml daily of pasteurized fermented milk (Inkomasi) or not. Changes in infant gut microbiota from enrollment to 4 weeks after enrollment will be compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with HIV HIV-exposed uninfected infants
排除标准
- 未提供
研究组 & 干预措施
Inkomasi
Diet supplementation with pasteurized fermented milk
干预措施: Inkomazi (Dietary Supplement)
Control
No intervention
结局指标
主要结局
Infant gut microbiome
时间窗: from enrollment to 4-10 weeks after enrollment
16s rRNA and metagenomic sequencing
Maternal gut microbiome
时间窗: 4-10 weeks after initiation of the intervention
Shotgun metagenomics and 16s rRNA
Infant gut microbiome
时间窗: from enrollment to 4-10 weeks after enrollment
16s rRNA and metagenomic sequencing
Maternal gut microbiome
时间窗: 4-10 weeks after initiation of the intervention
Shotgun metagenomics and 16s rRNA
次要结局
未报告次要终点
研究者
Adriana Weinberg
Professor of Pediatrics, Medicine and Pathology
University of Colorado, Denver