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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
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)
The placebo sticks will contain approximately 1 g maltodextrin
Plasma LPS levels
To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.
Time frame: 32 Weeks
Stool colonization with Lactobacillus plantarum
To quantify the extent that Lactobacillus plantarum populates fecal samples obtained over time in HIV-infected youth receiving probiotics.
Time frame: 32 Weeks
Plasma pro-inflammatory cytokines and macrophage activation
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.
Time frame: 32 Weeks
Lymphocyte activation markers
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.
Time frame: 32 Weeks
Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count
To examine if probiotics have any impact on quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count among the study cohort.
Time frame: 32 Weeks
Stool microbial composition and genetic diversity
To molecularly characterize changes in overall bacteria diversity within the stool specimens of youth treated with probiotics.
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Time frame: 32 Weeks
Safety labs and adverse events as a measure of acceptability and tolerability of probiotics
To examine the acceptability and tolerability of probiotics when administered to HIV-infected youth.
Time frame: 32 Weeks
Food frequency and probiotics and lifestyle questionnaires
To explore the effect of diet, smoking, and dietary supplements on plasma pro-inflammatory cytokine levels.
Time frame: 32 Weeks