Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
2017年2月27日 更新者：University of North Carolina, Chapel Hill
A Randomized Placebo-Controlled Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
This is a randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum LPS levels and immune activation among HIV-infected youth.
研究概览
详细说明
This is a double masked randomized placebo-controlled trial to examine if once daily probiotic therapy will lower serum lipopolysaccharide (LPS) levels and immune activation among HIV-infected youth.
The study will enroll two cohorts: (1) a cohort of subjects who are not receiving antiretroviral therapy (ART) and have absolute CD4 T-cell count greater than 350 cells/ul and quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml; and (2) a cohort of subjects who are receiving ART and have absolute CD4 T-cell count greater than 350 cells/ul and and quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml.
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 至 24年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
To be considered eligible for enrollment, an individual must meet the criteria listed below.
- Age 13 years and 0 days to 24 years and 364 days at the time of consent
- Confirmed or suspected to have acquired HIV infection at age 10 years or older
- HIV-1 infection as documented by any FDA-approved ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, HIV-1 DNA, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to pre-entry
- Absolute CD4 T-cell count greater than 350 cells/ul at pre-entry
- Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 50,000 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry
- Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Quantitative HIV-1 plasma RNA (viral load) less than 400 copies/ml on two consecutive determinations at least 8 weeks apart in the 24 weeks prior to and including pre-entry
- Willingness to refrain from regular use of foods/supplements containing probiotics other than that supplied by the study during the course of study participation
Exclusion Criteria:
To be considered eligible for enrollment, an individual must not meet any of the criteria listed below.
- Known hypersensitivity to probiotics
- Active AIDS-defining condition or acute serious illness
- Cohort 1 - Not receiving ART and no exposure to ART in the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 50,000 copies/ml during the 24 weeks prior or at pre-entry.
- Cohort 2 - Currently receiving ART and received ART for at least the 24 weeks prior to pre-entry: Any quantitative HIV-1 plasma RNA (viral load) equal to or greater than 400 copies/ml during the 24 weeks prior or at pre-entry
- Known history of inflammatory bowel disease or similar disorder of the GI tract
- Current treatment with immune-modulating or immune-suppressive therapy
- Active malignancy at pre-entry
- Pregnancy
- Grade 3 or higher clinical or laboratory toxicities at the time of randomization
- Regular use of foods or supplements containing probiotics within the 2 weeks prior to randomization (see Appendix V)
- Concurrent participation in the ATN 061, 071, 081, and/or 101 protocols
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo
Subjects randomized to the placebo arm.
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The placebo sticks will contain approximately 1 g maltodextrin
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实验性的：Probiotics
The probiotics use in the study contains two strains of Lactobacillus plantarum.
Each dose of the active study agent contains contains 1 g maltodextrin plus the probiotic bacteria Lp299v (5 x 109 cfu) and Lp299 (5 x 109 cfu).
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Probiotic is a live microorganism that when administered in adequate amounts confer a health benefit on the host.
It is classified by the FDA as "generally recognized as safe" (GRAS)
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Plasma LPS levels
大体时间：32 Weeks
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To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.
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32 Weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Stool colonization with Lactobacillus plantarum
大体时间：32 Weeks
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To quantify the extent that Lactobacillus plantarum populates fecal samples obtained over time in HIV-infected youth receiving probiotics.
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32 Weeks
|
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Plasma pro-inflammatory cytokines and macrophage activation
大体时间：32 Weeks
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To determine if probiotic colonization of the gastrointestinal (GI) tract with Lactobacillus plantarum decreases levels of plasma pro-inflammatory cytokines and macrophage activation by measuring tumor necrosis factor alpha (TNFα), interferon alpha (IFNα), interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-12p70 (IL-12p70), interleukin-10 (IL-10), and soluble CD14 (sCD14) as well as other markers of microbial translocation.
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32 Weeks
|
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Lymphocyte activation markers
大体时间：32 Weeks
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To determine if probiotic colonization of the GI tract with Lactobacillus plantarum results in decreased levels of T-cell activation markers as measured by shedding of soluble CD27 (sCD27), proportion of CD4 Th17 subsets, and expression of CD38 and HLA DR on CD8 T cells within ART treated and untreated HIV-infected youth.
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32 Weeks
|
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Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count
大体时间：32 Weeks
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To examine if probiotics have any impact on quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count among the study cohort.
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32 Weeks
|
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Stool microbial composition and genetic diversity
大体时间：32 Weeks
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To molecularly characterize changes in overall bacteria diversity within the stool specimens of youth treated with probiotics.
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32 Weeks
|
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Safety labs and adverse events as a measure of acceptability and tolerability of probiotics
大体时间：32 Weeks
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To examine the acceptability and tolerability of probiotics when administered to HIV-infected youth.
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32 Weeks
|
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Food frequency and probiotics and lifestyle questionnaires
大体时间：32 Weeks
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To explore the effect of diet, smoking, and dietary supplements on plasma pro-inflammatory cytokine levels.
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32 Weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：John Sleasman, MD、University of South Florida
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年12月1日
初级完成 (预期的)
2012年12月1日
研究完成 (预期的)
2012年12月1日
研究注册日期
首次提交
2011年11月4日
首先提交符合 QC 标准的
2011年12月14日
首次发布 (估计)
2011年12月15日
研究记录更新
最后更新发布 (实际的)
2017年2月28日
上次提交的符合 QC 标准的更新
2017年2月27日
最后验证
2016年2月1日
更多信息
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