NCT02164344

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:

  1. 1.to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics.
  2. 2.to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

June 11, 2014

Last Update Submit

June 12, 2014

Conditions

HIV

Keywords

HIVGutprobioticsimmune activation

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 months

Secondary Outcomes (2)

  • Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+

    3 months

  • CD4 recovery (ΔCD4)

    3 months

Study Arms (1)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: probiotics

Interventions

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)

Probiotics

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • intestinal diseases
  • opportunistic diseases
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Public Health and Infectious Diseases, University of Rome "Sapienza", Italy

Rome, RM, 00161, Italy

Location

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

Rome, 00161, Italy

Location

Related Publications (1)

  • 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.

    PMID: 26376436DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Vincenzo Vullo, MD

    University of Rome "Sapienza" (Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MSc

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 16, 2014

Study Start

January 1, 2013

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-03

Locations

IT(2)