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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Title Effect of Microbial Translocation and Supplementation With the Probiotic VSL#3 on Neuro-cognitive Functions of HIV Positive Patients Receiving HAART

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.


Detailed Summary:

The HIV virus has a marked tropism for the central nervous system. In 1986, the term AIDS Dementia Complex (ADC) has been coined which includes in a single syndrome, a whole series of severe neurologic manifestations, characterized by cognitive, motor and behavioral disorders.

The introduction of HAART has led to a profound change of the neurological HIV-mediated profile.

The increased morbidity that occurs in HIV patients on antiretroviral therapy is related to inflammatory processes and cardiovascular diseases, resulting from the damage of the mucosa of the gastrointestinal tract.

The massive depletion of CD4 T cells in the GI tract, low frequencies of CD4 and CD8 T producing IL-17, apoptosis of enterocytes (resulting in structural damage to the barrier of the GI tract) and the increase in intestinal permeability, are all manifestations of progressive HIV infection in humans.

The main consequence of the structural and functional disruption of the enteric mucosal barrier is constituted by the passage into the systemic circulation of products of microbial origin including the lipopolysaccharide (LPS), a phenomenon known as "microbial translocation" (MT). A direct consequence of MT is the increase in the levels of systemic innate and adaptive immune activation. The alteration of the intestinal mucosa also involves changes in the composition of the local microbial flora, event that changes the normal balance of the so-called axis "brain-gut", the function of this axis is in fact influenced by metabolic products of the resident bacterial flora.

The disturbance of this balance can cause diseases such as anxiety and depression

  • 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)
  • 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)
  • 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)


    • Original Primary Outcome: Same as current

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

    Original Secondary Outcome: Same as current

    Information By: Azienda Policlinico Umberto I

    Dates:
    Date Received: October 17, 2014
    Date Started: July 2014
    Date Completion: March 2018
    Last Updated: December 2, 2016
    Last Verified: December 2016