HIV -1 InfectionPhase 2NCT01908049
Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.
A Phase 2 study testing Probiotic. in people with HIV -1 Infection, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV -1 Infection
- What is being tested?
- Probiotic.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2012to Mar 2017
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic HIV infection and viral load undetectable > two years with stable ART CD4> 400 cells / ml.
- Patients with chronic HIV infection and viral load undetectable> two years with stable ART CD4 <350 cells / ml.
- Inform consent signed.
- Aged between 18- No limit.
Who cannot join
- Patients who receive or have received in the past 6 months food supplements containing probiotics.
- Patients who have received antibiotic treatment in the last two months
- Patients who are poor presupposes adherence to dietary supplements.
- Patients who have changed the TAR in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition.
SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics.
Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.
- Conditions
- HIV -1 Infection
- Being tested
- Probiotic., Placebo
- Keywords
- Probiotic, HIV, Microbial translocation, inflammation, microbiota composition
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic.Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks. Receives: Dietary Supplement: Probiotic. |
| Placebo | Placebo comparator | No active substance is given. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP).
Measured: From randomisation to 6 months.
To evaluate Gut microbiota composition.
Change in gut microbiota (454 pyrosequencing of fecal samples).
Measured: From randomisation to 6 months.
Secondary outcomes (2)
To evaluate Markers of immune activity: soluble CD14 (sCD14), interferon gamma (IFN-Υ), tumor necrosis factor (TNF), IL-6, Reactive C protein, D -dimer, fibrinogen.
Measured: From randomisation to 6 months.
Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load.
Measured: From randomisation to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JVillar, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908049
- Sponsor's protocol ID
- PROB-VIH
- Status last verified
- Nov 2016
- First submitted
- 22 Jul 2013
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Villar-Garcia J, Hernandez JJ, Guerri-Fernandez R, Gonzalez A, Lerma E, Guelar A, Saenz D, Sorli L, Montero M, Horcajada JP, Knobel Freud H. Effect of probiotics (Saccharomyces boulardii) on microbial translocation and inflammation in HIV-treated patients: a double-blind, randomized, placebo-controlled trial. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):256-63. doi: 10.1097/QAI.0000000000000468.
PubMed 25469528
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Probiotics (Saccharomyces Boulardii) and Its Role in Bacterial Translocation and Immune Reconstitution in VIH Infection.
- ClinicalTrials.gov ID
- NCT01908049
- Acronym / sponsor ID
- PROB-VIH
- Conditions
- HIV -1 Infection
- Keywords
- Probiotic, HIV, Microbial translocation, inflammation, microbiota composition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Jul 2013 (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.
Objectives: MAIN: To evaluate the parameters of microbial translocation after treatment with probiotics (Saccharomyces boulardii) in HIV+ patients and its role on immune reconstitution and the changes in gut microbiota composition.
SECONDARY OBJECTIVES: 1) To analyze the progress of immune activity markers after the administration of probiotics. 2) To determine the improvement of CD4+ lymphocytes and HIV viral load in patients after taking probiotics.
Methods: Design: A prospective randomized open controlled double-blinded trial, to be performed at a tertiary care hospital in Barcelona. Subjects: Chronic HIV infected patients. Sample size: 44 cases. They´ll be divided in 2 groups: (1) Patients with CD4 +> 400 cells / ml and undetectable viral load for more than two years (22 cases) and (2) Patients with immunodiscordancy, defined as patients with CD4 + T cells lower than 350 cells / ml despite 4-7 years of effective antiretroviral therapy. (22 cases). Intervention: Patients were randomized in 2 subgroups: (A) they´ll receive daily oral supplementation with S. boulardii for 3 months and (B) they ´ll receive placebo. Variables: bacterial lipopolisaccharide levels measured by the Lipid-Binding protein (LBP), parameters of immune activation in plasma (soluble CD14, IFN-Υ, TNF-Alpha, IL (interleukine)-2, IL-5, IL-6, IL-12)and gut microbiota composition prior to the use of probiotics (baseline), at 3 and 6 months. Immunological and clinical data. Outcome measures: quantification of bacterial translocation levels, markers of activity and immune recovery. Analysis: Comparison of variables before and after the intervention. The analysis will be performed by biological and immunological effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic.A probiotic (Saccharomyces boulardii) 2 caps/ 8h for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNo active substance is given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic HIV infection and viral load undetectable > two years with stable ART CD4> 400 cells / ml.
- Patients with chronic HIV infection and viral load undetectable> two years with stable ART CD4 <350 cells / ml.
- Inform consent signed.
- Aged between 18- No limit.
Key exclusion criteria (4 listed)
- Patients who receive or have received in the past 6 months food supplements containing probiotics.
- Patients who have received antibiotic treatment in the last two months
- Patients who are poor presupposes adherence to dietary supplements.
- Patients who have changed the TAR in the last three months.
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 |
|---|---|---|
| Probiotic. | Dietary supplement | Probiotic |
| Placebo | Dietary supplement | Placebo |
Primary outcome
To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP).
Time frame: From randomisation to 6 months.
To evaluate Gut microbiota composition.
Time frame: From randomisation to 6 months.
Change in gut microbiota (454 pyrosequencing of fecal samples).
2 secondary outcomes
To evaluate Markers of immune activity: soluble CD14 (sCD14), interferon gamma (IFN-Υ), tumor necrosis factor (TNF), IL-6, Reactive C protein, D -dimer, fibrinogen.
Time frame: From randomisation to 6 months.
Analyse parameters that determine the immune status: CD4 + lymphocyte count, CD 8 + and HIV viral load.
Time frame: From randomisation to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 25469528Villar-Garcia J, Hernandez JJ, Guerri-Fernandez R, Gonzalez A, Lerma E, Guelar A, Saenz D, Sorli L, Montero M, Horcajada JP, Knobel Freud H. Effect of probiotics (Saccharomyces boulardii) on microbial translocation and inflammation in HIV-treated patients: a double-blind, randomized, placebo-controlled trial. J Acquir Immune Defic Syndr. 2015 Mar 1;68(3):256-63. doi: 10.1097/QAI.0000000000000468.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic. in people with HIV -1 Infection, run by Parc de Salut Mar at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To evaluate microbial translocation-Binding lipopolysaccharide Protein (LBP). (time frame: From randomisation to 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908049, which also lists 1 linked publication.
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 15 Nov 2016.