Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
|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Recruitment Status : Withdrawn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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492803
|Study Chair:||John Sleasman, MD||University of South Florida|