Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders (PROCOG)
Primary Purpose
HIV, Neurocognitive Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vivomixx
Sponsored by
About this trial
This is an interventional other trial for HIV
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
Sites / Locations
- CH CannesRecruiting
- CHU Montpellier
- CHU de NiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
probiotics
without probiotic
Arm Description
probiotic administration
no change from the usual care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04175223
First Posted
September 6, 2019
Last Updated
July 21, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04175223
Brief Title
Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders
Acronym
PROCOG
Official Title
Study to Measure the Impact of Probiotics on Immune Activation and Neurocognitive Disorders in HIV-positive Patients With Neurocognitive Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
April 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Neurocognitive Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
probiotics
Arm Type
Experimental
Arm Description
probiotic administration
Arm Title
without probiotic
Arm Type
No Intervention
Arm Description
no change from the usual care
Intervention Type
Dietary Supplement
Intervention Name(s)
Vivomixx
Intervention Description
probiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months
Primary Outcome Measure Information:
Title
measurement of the immune activation and Serum inflammation markers
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chrisine LEBRUN FRENAY, PUPH
Phone
33492038754
Email
lebrun-frenay.c@chu-nice.fr
Facility Information:
Facility Name
CH Cannes
City
Cannes
ZIP/Postal Code
06400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
matteo vassallo, ph
Email
m.vassallo@ch-cannes.fr
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques Reynes, PUPH
Email
j-reynes@chu-montpellier.fr
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine LEBRUN FRENAY, PUPH
Phone
33492038754
Email
lebrun-frenay@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Jacques DURANT
First Name & Middle Initial & Last Name & Degree
christine LEBRUN-FRENAY
12. IPD Sharing Statement
Learn more about this trial
Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders
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