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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
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HIV Infection | Dietary Supplement: Probiotics Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
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 |

Arm | Intervention/treatment |
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Placebo Comparator: Placebo
Subjects randomized to the placebo arm.
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Dietary Supplement: Placebo
The placebo sticks will contain approximately 1 g maltodextrin
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Experimental: 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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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.
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- 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.

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Ages Eligible for Study: | 13 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 |
Additional Information:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01492803 History of Changes |
Other Study ID Numbers: |
ATN 097 |
First Posted: | December 15, 2011 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | February 2016 |
Keywords provided by University of North Carolina, Chapel Hill:
HIV infection Probiotics |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |