HIV InfectionNCT01492803
Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
A study testing Probiotics in people with HIV Infection, run by University of North Carolina, Chapel Hill.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- HIV Infection
- Being tested
- Probiotics, Placebo
- Keywords
- HIV infection, Probiotics
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called No other names.
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)
PlaceboDietary supplement
The placebo sticks will contain approximately 1 g maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects randomized to the placebo arm. Receives: Dietary Supplement: Placebo |
| Probiotics | Experimental | 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). Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma LPS levels
To determine if once daily probiotic therapy decreases microbial translocation in HIV-infected youth as measured by changes in plasma LPS.
Measured: 32 Weeks
Secondary outcomes (7)
Stool colonization with Lactobacillus plantarum
To quantify the extent that Lactobacillus plantarum populates fecal samples obtained over time in HIV-infected youth receiving probiotics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 32 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- John Sleasman, MD, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492803
- Sponsor's protocol ID
- ATN 097
- Status last verified
- Feb 2016
- First submitted
- 4 Nov 2011
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Trial of Probiotics to Lower Microbial Translocation and Immune Activation in HIV-Infected Adolescents
- ClinicalTrials.gov ID
- NCT01492803
- Acronym / sponsor ID
- ATN 097
- Conditions
- HIV Infection
- Keywords
- HIV infection, Probiotics
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects randomized to the placebo arm. |
| Probiotics | Experimental | Dietary Supplement: ProbioticsThe 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). |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsAlso: No other names.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) | Dietary supplement | Probiotics |
| PlaceboThe placebo sticks will contain approximately 1 g maltodextrin | Dietary supplement | Placebo |
Primary outcome
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.
7 secondary outcomes
Stool colonization with Lactobacillus plantarum
Time frame: 32 Weeks
Plasma pro-inflammatory cytokines and macrophage activation
Time frame: 32 Weeks
Lymphocyte activation markers
Time frame: 32 Weeks
Quantitative HIV-1 plasma RNA (viral load) and CD4 T-cell count
Time frame: 32 Weeks
Stool microbial composition and genetic diversity
Time frame: 32 Weeks
Safety labs and adverse events as a measure of acceptability and tolerability of probiotics
Time frame: 32 Weeks
Food frequency and probiotics and lifestyle questionnaires
Time frame: 32 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- ATN websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Sleasman, MD study chair
University of South Florida
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with HIV Infection, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma LPS levels (time frame: 32 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.