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Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy (PROBIO-HIV)

Primary Purpose

HIV

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
probiotics
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Gut, probiotics, immune activation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • HIV positive patients
  • HIV viral load < 50 copies/ml
  • antiretroviral therapy from at least 2 years

Exclusion Criteria:

  • intestinal diseases
  • opportunistic diseases
  • pregnancy

Sites / Locations

  • Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
  • Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotics

Arm Description

HIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+
Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)
CD4 recovery (ΔCD4)
CD4 recovery (ΔCD4),in blood at T0 and T1

Full Information

First Posted
June 11, 2014
Last Updated
June 12, 2014
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02164344
Brief Title
Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy
Acronym
PROBIO-HIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, Gut, probiotics, immune activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
HIV-1 infected patients take daily dietary supplement with probiotics for at least 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)
Primary Outcome Measure Information:
Title
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
Description
Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+
Description
Delta of CD8+/CD38-/HLA-DR+ in blood (T0-T1)
Time Frame
3 months
Title
CD4 recovery (ΔCD4)
Description
CD4 recovery (ΔCD4),in blood at T0 and T1
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: HIV positive patients HIV viral load < 50 copies/ml antiretroviral therapy from at least 2 years Exclusion Criteria: intestinal diseases opportunistic diseases pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Vullo, MD
Organizational Affiliation
University of Rome "Sapienza" (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy
City
Rome
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
Department of Public Health and Infectious Diseases. University of Rome "Sapienza" (Italy)
City
Rome
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26376436
Citation
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.
Results Reference
derived

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Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy

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