Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of VSL#3 on Neuro-cognitive Profile of HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02276326
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Dott.ssa Gabriella D'Ettorre, Azienda Policlinico Umberto I

Brief Summary:

Aim of the study is to evaluate the effects of a change in the intestinal microflora on the neuro-cognitive profile of patients with HIV infection receiving HAART treatment. Improvements will be evaluated with questionnaires on Quality of life and Cognitive and Behavior function.

20 patients will be enrolled and will receive 4 sachets of VSL#3 per day.


Condition or disease Intervention/treatment Phase
HIV Seropositivity ART Dietary Supplement: VSL#3 sachets Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Title Effect of Microbial Translocation and Supplementation With the Probiotic VSL#3 on Neuro-cognitive Functions of HIV Positive Patients Receiving HAART
Study Start Date : July 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: VSL#3 sachets
VSL#3 is a mix of lactic acid bacteria and bifidobacteria (original De Simone's formulation)
Dietary Supplement: VSL#3 sachets
4 sachets a day for 4 months




Primary Outcome Measures :
  1. Delta of scores of questionnaires on quality of life [ Time Frame: 4 months ]
    HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)

  2. Delta of scores of questionnaires on cognitive functions [ Time Frame: 4 months ]
    HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)

  3. Delta of scores of questionnaires on behavioral functions [ Time Frame: 4 months ]
    HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)


Secondary Outcome Measures :
  1. Delta of value of serum lipopolysaccharide (LPS) [ Time Frame: between time 0 and after 4 months of assumption of VSL#3 ]

Other Outcome Measures:
  1. Delta of Cluster of Differentiation 14 (CD14)+ in blood (T0-T1) [ Time Frame: between time 0 and after 4 months of assumption ]
  2. Delta of value of serum lipopolysaccharide binding protein (LBP) [ Time Frame: between time 0 and after 4 months of assumption ]
  3. Delta of value of serum EndoCAb [ Time Frame: between time 0 and after 4 months of assumption ]
  4. Delta of value of serum hs-CRP [ Time Frame: between time 0 and after 4 months of assumption ]
  5. Delta of value of serum IL-6 [ Time Frame: between time 0 and after 4 months of assumption ]
  6. Delta of value of serum TNFa [ Time Frame: between time 0 and after 4 months of assumption ]
  7. Delta of value of serum MIP-lb [ Time Frame: between time 0 and after 4 months of assumption ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at least 18 years of age
  • In HAART with HIV RNA <50cp/mL, with CD4 counts> 400 cells / mm
  • Availability to release informed consent

Exclusion Criteria:

  • Patients with known allergy or intolerance to VSL#3
  • Chronic inflammatory bowel diseases
  • Drug addiction
  • Use of antibiotics or probiotics during the 3 weeks prior the enrollment
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276326


Locations
Layout table for location information
Italy
Policlinico Umberto I Hospital Recruiting
Rome, Italy, 00155
Contact: Gabriella D'Ettorre       gabriella.dettorre@uniroma1.it   
Principal Investigator: Gabriella D'Ettorre         
Principal Investigator: Vincenzo Vullo         
Sub-Investigator: Giancarlo Ceccarelli         
Sponsors and Collaborators
Azienda Policlinico Umberto I
Investigators
Layout table for investigator information
Principal Investigator: Gabriella D'Ettorre Policlinico Umberto I Hospital

Publications of Results:
Layout table for additonal information
Responsible Party: Dott.ssa Gabriella D'Ettorre, PhD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT02276326     History of Changes
Other Study ID Numbers: VSL-Dett 2014
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: December 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases