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临床试验/NCT02276326
NCT02276326已完成不适用

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

Azienda Policlinico Umberto I2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Delta of scores of questionnaires on quality of life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Delta of scores of questionnaires on quality of life

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

  • Delta of value of serum lipopolysaccharide (LPS)(between time 0 and after 4 months of assumption of VSL#3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriella D'Ettorre

PhD

Azienda Policlinico Umberto I

研究点 (2)

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