HIVPROBIO-HIVNCT02164344
Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy
A study testing probiotics in people with HIV, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2013to Jul 2014
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV positive patients
- HIV viral load < 50 copies/ml
- antiretroviral therapy from at least 2 years
Who cannot join
- intestinal diseases
- opportunistic diseases
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
Rome, RM, 00161
Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy)
Rome, 00161
About this study
Official title: Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy and Non-virological Study of the Effects of Therapy
Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation.
None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause.
Read more
In this longitudinal study we aim:
- to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics.
- to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status
Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.
- Conditions
- HIV
- Being tested
- probiotics
- Keywords
- HIV, Gut, probiotics, immune activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | HIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months Receives: Dietary Supplement: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)
Measured: 3 months
Secondary outcomes (2)
Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+
Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)
Measured: 3 months
CD4 recovery (ΔCD4)
CD4 recovery (ΔCD4),in blood at T0 and T1
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionJul 2014 (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 HIVStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giancarlo Ceccarelli, University of Roma La Sapienza
- Investigators
- Vincenzo Vullo, MD, Principal investigator, University of Rome "Sapienza" (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164344
- Sponsor's protocol ID
- DPHID-UniRoma03
- Acronym
- PROBIO-HIV
- Status last verified
- Mar 2014
- First submitted
- 11 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
d'Ettorre G, Ceccarelli G, Giustini N, Serafino S, Calantone N, De Girolamo G, Bianchi L, Bellelli V, Ascoli-Bartoli T, Marcellini S, Turriziani O, Brenchley JM, Vullo V. Probiotics Reduce Inflammation in Antiretroviral Treated, HIV-Infected Individuals: Results of the "Probio-HIV" Clinical Trial. PLoS One. 2015 Sep 16;10(9):e0137200. doi: 10.1371/journal.pone.0137200. eCollection 2015.
PubMed 26376436
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy and Non-virological Study of the Effects of Therapy
- ClinicalTrials.gov ID
- NCT02164344
- Acronym / sponsor ID
- PROBIO-HIV / DPHID-UniRoma03
- Conditions
- HIV
- Keywords
- HIV, Gut, probiotics, immune activation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 16 Jun 2014 (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.
Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation.
None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause.
In this longitudinal study we aim:
- to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics.
- to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status
Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: probioticsHIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV positive patients
- HIV viral load < 50 copies/ml
- antiretroviral therapy from at least 2 years
Key exclusion criteria (3 listed)
- intestinal diseases
- opportunistic diseases
- pregnancy
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 |
|---|---|---|
| probioticsprobiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium) | Dietary supplement | Probiotics |
Primary outcome
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
Time frame: 3 months
Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)
2 secondary outcomes
Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+
Time frame: 3 months
CD4 recovery (ΔCD4)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
- Derived from this study: PubMed 26376436d'Ettorre G, Ceccarelli G, Giustini N, Serafino S, Calantone N, De Girolamo G, Bianchi L, Bellelli V, Ascoli-Bartoli T, Marcellini S, Turriziani O, Brenchley JM, Vullo V. Probiotics Reduce Inflammation in Antiretroviral Treated, HIV-Infected Individuals: Results of the "Probio-HIV" Clinical Trial. PLoS One. 2015 Sep 16;10(9):e0137200. doi: 10.1371/journal.pone.0137200. eCollection 2015.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Vincenzo Vullo, MD principal investigator
University of Rome "Sapienza" (Italy)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with HIV, run by University of Roma La Sapienza at 2 sites in Italy.
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 3 inclusion and 3 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 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. 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?
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?
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+) (time frame: 3 months). 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 NCT02164344, 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 16 Jun 2014.