Vivomixx
Dietary Supplementprobiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months
NCT Number: NCT04175223
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
CH Cannes, Cannes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
probiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months
Time frame: 6 months
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.
Centre Hospitalier Universitaire de Nice
Other
Study to Measure the Impact of Probiotics on Immune Activation and Neurocognitive Disorders in HIV-positive Patients With Neurocognitive Disorders
Acronym: PROCOG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06125509
HIV
Tallahassee, Florida, United States
View Trial DetailsNCT07225894
Behavior, HIV
Kisumu, Kisumu County, Kenya
View Trial DetailsNCT02447159
Behavior, Blood-Borne Infections
Eket, Akwa Ibom State, Nigeria
View Trial DetailsNCT03734393
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Birmingham, Alabama, United States
View Trial Details