Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders

NCT ID: NCT04175223

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-19
• Study Completion Date: 2024-05-15

Brief Summary

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.

Conditions

HIV; Neurocognitive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

probiotics

probiotic administration

Group Type: EXPERIMENTAL

Vivomixx

Intervention Type: DIETARY_SUPPLEMENT

probiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months

without probiotic

no change from the usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vivomixx

probiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients who have signed informed consent
• Patients infected with HIV-1
• Patients with undetectable viral load and stable antiretroviral therapy for at least 6 months
• Patients with HIV-related neurocognitive disorders of the ANI or MND type, to be confirmed by neuropsychological assessment at inclusion
• Outpatient patients, over 18 years of age
• Patients with social security coverage

Exclusion Criteria

• Patients infected with HIV-2
• Patients who have not been on stable antiretroviral therapy and have been virologically successful for at least 6 months
• Patients who have been treated during the primary infection phase, taking into account the potential risks of impact on intestinal lymphocyte apoptosis and therefore on the microbiota
• Patients who do not have HIV-related neurocognitive disorders such as ANI or MND
• Patients refusing to participate in the study
• Patients consuming probiotics at inclusion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CH Cannes

Cannes, , France

CHU Montpellier

Montpellier, , France

CHU de Nice

Nice, , France

Countries

France

Other Identifiers

19-AOI-03

Identifier Type: -

Identifier Source: org_study_id