The Effect of Probiotics on Microbial Translocation and Inflammation in HIV-infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention
研究概览
简要总结
Objective:
In this study the investigators aim at investigating:
- probiotics ability to modulate the microbiome and microbial translocation,
- if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and
- if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract.
Design:
The study is a prospective clinical intervention trial of 40 HIV-infected patients.
Method:
The investigator will administer the bacteria Lactobacillus Rhamnosus in capsular form to each patient 2 times a day in 8 weeks. At baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •confirmed HIV
- •no HIV treatment
- •cluster of differentiation 4+ cell count over 350
排除标准
- •antibiotic or probiotic in last 2 month
- •drugs that influence gut motility
- •Inflammatory bowel disease
- •autoimmune diseases
研究组 & 干预措施
HIV-infected patients
Probiotics (lactobacillus rhamnosus)
干预措施: Probiotic (Drug)
结局指标
主要结局
change in Lipopolysaccharide (unit= endotoxin unit/mL) from baseline after intervention
时间窗: Will be measured before and after eight weeks of intervention.
will be measured in plasma samples
次要结局
- Changes in of high sensitive C-reactive protein (unit mg/l) from baseline and after eight weeks of intervention(Will be measured before and after eight weeks of intervention.)
- change in soluble cluster of differentiation 14 (unit (ng/mL) from baseline and eight weeks after intervention.(Will be measured before and after eight weeks of intervention.)
- change in inflammation around the gut measured with positron emission tomography-magnetic resonance scans of the abdomen ( size of the lymph nodes and positron emission tomography-activity)(Will be measured before and after eight weeks of intervention.)
- Changes in measures of cytokines unit (pg/ml) at baseline and after eight weeks of intervention(Will be measured before and after eight weeks of intervention.)
- Changes in the gut microbiota composition (454 pyrosequencing of fecal samples) from baseline to eight weeks after intervention (end of study)(Will be measured before and after eight weeks of intervention.)
研究者
Susanne Dam Nielsen, MD
Associate Professor
Rigshospitalet, Denmark