Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06139224
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • 4 week prebiotic consumption — DIETARY_SUPPLEMENT
    For this crossover design, participants will be randomly assigned to take a prebiotic or placebo for 4 weeks and then switch to the other products. Participants and research coordinators will be blinded. Participants will be instructed to consume the prebiotic daily during the first three days and then twice daily for the remaining weeks. Participants will be instructed to consume the powder in the morning on the first three days, then in the morning and afternoon for the following weeks. They will record their prebiotic consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator.
  • 4 week placebo consumption — OTHER
    For this crossover design, participants will be randomly assigned to take a prebiotic or placebo for 4 weeks and then switch to the other products. Participants and research coordinators will be blinded. Participants will be instructed to consume the placebo (maltodextrin) daily during the first three days and then twice daily for the remaining weeks. Participants will be instructed to consume the powder in the morning on the first three days, then in the morning and afternoon for the following weeks. They will record their prebiotic consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator.

Study Details

Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans. 40 HIV+ ART+ (20 AUD- and 20 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept intervention study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will complete three in-person clinic visits and four virtual check-in visits during this 8 week study. This study uses a crossover design. At baseline, participants will be randomized to receive either a prebiotic or a placebo for the first intervention period. After completing this period, participants will cross over to receive the alternate study product for the second intervention period, allowing each participant to serve as their own control. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. New participants will also be recruited. Blood, urine, and stool, will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois.

Key Dates

Start date
Mar 5, 2024
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: HIV-infected ART-suppressed individuals with AUD
    Only 20 HIV+ ART+,AUD + individuals will be invited to take part in a prebiotic sub study, which they will take a prebiotic for 4 weeks and placebo for 4 weeks.
  • Experimental: HIV-infected ART-suppressed individuals with no AUD
    Only 20 HIV+ ART+,AUD - individuals will be invited to take part in a prebiotic sub study, which they will take a prebiotic for 4 weeks and placebo for 4 weeks.

Primary Outcome Measure

Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ali KeshavarzianChicagoIllinois60612
Ali Keshavarzian, M.D.
[email protected]
312-563-4175

Find similar trials in Chicago, IL

By condition
Substance use disorderHIV
By specialty
Behavioral healthAddiction medicineInfectious disease
By research site
Ali Keshavarzian· Chicago, IL

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