An interventional study of Vivomixx in HIV and Neurocognitive Disorders, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other
The prevalence of HIV-associated neurocognitive disorders (Human Immunodeficiency Virus) remains high during the era of effective triple therapy. The main clinical phenotypes of cognitive impairment are currently represented by asymptomatic neurocognitive neurocognitive impairment (ANI) and mild neurocognitive disorders (MND). In contrast, HIV-associated dementia has almost disappeared.
Among the hypotheses to explain the persistence of such a high prevalence is the persistent activation of the immune system despite virological success. This chronic immune activation is believed to be responsible for an inflammatory response and therefore for accelerated cell aging. Several organ complications in HIV-positive patients have been associated with high markers of immune activation.
Among the causes of chronic immune activation in virologically controlled patients, an imbalance in the intestinal flora is suspected. In fact, shortly after HIV infection, the virus causes significant apoptosis of intestinal lymphocytes, responsible for a loss of integrity of the intestinal barrier and an imbalance of flora, defined as "dysbiosis".
Loss of epithelial integrity and intestinal dysbiosis are suspected of causing systemic passage of bacterial fragments, of which lypopolisaccharide is best known, resulting in chronic activation of the immune system. Several studies suggest a link between digestive bacterial translocation and HIV-related neurocognitive disorders. An improvement in intestinal dysbiosis could therefore contribute to reducing immune activation and the severity of cognitive impairment. A recent study showed that probiotics can reduce levels of neopterin, a marker of monocytic activation, in the cerebrospinal fluid of HIV-positive patients without neurological symptoms.
Our objective is to evaluate the impact of probiotic supplementation on immune activation and cognitive performance in virologically controlled HIV-positive patients with a diagnosis of ANI or MND. The potential improvement of cognition through probiotic treatment could therefore improve their quality of life at a lower cost than a drug and without the risk of serious side effects.
246 studies on the registry are indexed under Neurocognitive Disorders; 88 are open to participants now.
This study's enrollment of 32 is below the median of 72 across 150 interventional studies indexed under Neurocognitive Disorders.
Browse Neurocognitive Disorders studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
probiotic administration
Dietary Supplement: Vivomixx
no change from the usual care
probiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months
measurement of the immune activation and Serum inflammation markers
The immune activation is composed with the following elements (quantity of serum immune activation and inflammation markers : sCD14 (ng/mL), sCD163 (ng/mL), TNF-alpha (ng/ml) , IL-1 (ng/ml) , IL-6 (ng/ml) , IL-8 (ng/ml) , D-Dimeres (ng/ml), hCRP (ng/ml), MCP-1(ng/ml), IP-10 (ng/ml), Neurofilaments light chain (log10 ng/ml) and Lipopolysaccharide (ng/ml)) , at inclusion and after 6 months of probiotic supplementation in the 2 groups wwith laboratory tests. The immune activation is the result of the multiple measurements. there is no units of measure and it's not an aggregation of the measurement.
Time frame: 6 months
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice