Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
27 februari 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
13 jaar tot 24 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Placebo
Subjects randomized to the placebo arm.
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The placebo sticks will contain approximately 1 g maltodextrin
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Experimenteel: 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)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Plasma LPS levels
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Stool colonization with Lactobacillus plantarum
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: John Sleasman, MD, University of South Florida
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2011
Primaire voltooiing (Verwacht)
1 december 2012
Studie voltooiing (Verwacht)
1 december 2012
Studieregistratiedata
Eerst ingediend
4 november 2011
Eerst ingediend dat voldeed aan de QC-criteria
14 december 2011
Eerst geplaatst (Schatting)
15 december 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 februari 2017
Laatste update ingediend die voldeed aan QC-criteria
27 februari 2017
Laatst geverifieerd
1 februari 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- ATN 097
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