Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
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|ClinicalTrials.gov Identifier: NCT01492803|
Recruitment Status : Withdrawn
First Posted : December 15, 2011
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Dietary Supplement: Probiotics Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Placebo-Controlled Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Placebo Comparator: Placebo
Subjects randomized to the placebo arm.
Dietary Supplement: Placebo
The placebo sticks will contain approximately 1 g maltodextrin
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).
Dietary Supplement: Probiotics
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)
Other Name: No other names.
- Plasma LPS levels [ Time Frame: 32 Weeks ]To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.
- Stool colonization with Lactobacillus plantarum [ Time Frame: 32 Weeks ]To quantify the extent that Lactobacillus plantarum populates fecal samples obtained over time in HIV-infected youth receiving probiotics.
- Plasma pro-inflammatory cytokines and macrophage activation [ Time Frame: 32 Weeks ]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.
- Lymphocyte activation markers [ Time Frame: 32 Weeks ]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.
- Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count [ Time Frame: 32 Weeks ]To examine if probiotics have any impact on quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count among the study cohort.
- Stool microbial composition and genetic diversity [ Time Frame: 32 Weeks ]To molecularly characterize changes in overall bacteria diversity within the stool specimens of youth treated with probiotics.
- Safety labs and adverse events as a measure of acceptability and tolerability of probiotics [ Time Frame: 32 Weeks ]To examine the acceptability and tolerability of probiotics when administered to HIV-infected youth.
- Food frequency and probiotics and lifestyle questionnaires [ Time Frame: 32 Weeks ]To explore the effect of diet, smoking, and dietary supplements on plasma pro-inflammatory cytokine levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492803
|Study Chair:||John Sleasman, MD||University of South Florida|