Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorRush University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 21 to 75 years men and women

Infection with HIV-1, as documented by a licensed ELISA and confirmed by a Western blot or HIV-1 RNA

On ART for at least 12 months. No history of zidovudine (AZT) or stavudine (D4T) use.

No change in ART for at least 6 months.

Disqualifiers

Receipt of a non-HIV vaccine within 30 days

Opportunistic infection within 30 days

Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 90 days

History of clinically significant medical disease that could potentially impact the integrity of intestinal barrier function or microbiota including renal (creatinine >2 mg/dL), liver (documented cirrhosis based on histology or ALT/AST greater than 2 1/2 times normal), cardiac failure (NY classification III/IV), or uncontrolled diabetes (Hgb-A1c>8%).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: HIV-infected ART-suppressed individuals with AUDExperimental treatment 2 interventions
Group B: HIV-infected ART-suppressed individuals with no AUDExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy

Measure the permeation of sugar probes following an oral test dose of sugars as this is standard for evaluating intestinal barrier integrity

Time frame
8 weeks

Secondary outcomes

1

Change in stool and intestinal microbiota composition after prebiotic and placebo consumption

A combination of 16S rRNA gene amplicon sequencing and shotgun metagenome sequencing will be used to characterize microbial community structure in intestinal biopsies and stool.

Time frame
8 weeks
2

Change in plasma and stool SCFA level before and after prebiotic treatment

Mass spectrometry and NMR

Time frame
8 weeks

Other outcomes

Sponsors and contacts

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