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NCT04175223Completed

Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders

Study to Measure the Impact of Probiotics on Immune Activation and Neurocognitive Disorders in HIV-positive Patients With Neurocognitive Disorders

Source: ClinicalTrials.gov · Last updated 17 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
32 (actual)
First submitted
6 Sept 2019
Start date
Sept 2019
Primary completion date
Dec 2021
Lead sponsor
Centre Hospitalier Universitaire de Nice
Diseases
HIV
NCT number
NCT04175223

What you commit to

  • Study type: Interventional
  • Participants enrolled: 32
  • From Sept 2019 to the primary completion date, Dec 2021
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have not been on stable antiretroviral therapy and have been virologically successful for at least 6 months

Other illness

  • Patients infected with HIV-2
  • Patients who do not have HIV-related neurocognitive disorders such as ANI or MND

Lab values

  • 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

Other

  • Patients refusing to participate in the study
  • Patients consuming probiotics at inclusion

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH Cannes
Coordinator of this site? Confirm its status
CannesFranceUnknown status
CHU Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
CHU de Nice
Coordinator of this site? Confirm its status
NiceFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.