NCT04175223: PROCOG

Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders

Completed NA Last updated 17 May 2024

What this trial tests

NA trial testing Vivomixx in HIV in 32 participants. Completed in 15 May 2024.

Timeline

19 September 2019

Primary endpoint
22 December 2021

15 May 2024

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	32
Start date	19 September 2019
Primary completion	22 December 2021
Estimated completion	15 May 2024
Sites	3 locations across France

Drugs / interventions tested

• Vivomixx — full drug profile →

Conditions studied

• HIV — all drugs for HIV →
• Neurocognitive Disorders — all drugs for Neurocognitive Disorders →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with HIV or Neurocognitive Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lights and Shadows of Microbiota Modulation and Cardiovascular Risk in HIV Patients.
   Villoslada-Blanco P, Pérez-Matute P, Oteo JA. · · 2021 · cited 4× · PMID 34202210 · DOI 10.3390/ijerph18136837