Actively Recruiting
Gut Microbiota-Mediated Inflammatory Interactions Between Alcohol Use Disorders and HIV Infection
Led by Rush University Medical Center · Updated on 2026-06-04
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how alcohol use disorder (AUD) affects inflammation and gut health in people living with HIV who are receiving antiretroviral therapy (ART). The study explores the idea that the combined impact of AUD and HIV worsens gut barrier function and inflammation, potentially through oxidative stress. The research also looks at whether short chain fatty acid prebiotics can improve gut barrier integrity and reduce inflammation in this group. The study involves 40 HIV-positive participants on ART, split into two groups: 20 with AUD and 20 without AUD. Using a crossover design, participants will take a prebiotic supplement or a placebo for 4 weeks each, switching after the first period. They will consume the powders daily at first and then twice daily, keeping a daily log of intake and any gastrointestinal symptoms. Weekly check-ins will support adherence and monitoring. Participants will attend three in-person clinic visits and four virtual check-ins over an 8-week period. Blood, urine, and stool samples will be collected to assess gut barrier integrity, inflammation, immune activation, oxidative stress, and microbiome changes. The main outcome is intestinal permeability measured by a sugar test after each intervention period. Researchers will also analyze changes in stool microbiota and plasma and stool levels of short chain fatty acids to understand the effects of the prebiotic compared to placebo.
CONDITIONS
Brief Title
Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 75 years, men and women
- Documented HIV-1 infection confirmed by licensed ELISA and Western blot or HIV-1 RNA test
- On antiretroviral therapy (ART) for at least 12 months with no changes in ART for at least 6 months
- CD4+ T cell count greater than 250 cells/µl
- Plasma HIV-1 RNA consistently below detection (<20 copies/mL) for at least six months
- For AUD group, AUDIT-C score ≥4 for men and ≥3 for women
- Body mass index (BMI) between 25 and 40
- Ability and willingness to provide informed consent
You will not qualify if you...
- Receipt of a non-HIV vaccine within 30 days prior to enrollment
- Opportunistic infection within 30 days prior to enrollment
- Use of immunosuppressive medications within 90 days prior to enrollment
- History of significant medical diseases affecting gut barrier or microbiota, including renal, liver, cardiac failure, or uncontrolled diabetes (Hgb-A1c >8%)
- Fiber intake greater than 15 grams daily
- Chronic hepatitis B or untreated hepatitis C (cured HCV allowed)
- Use of herbal/botanical supplements affecting microbiome or inflammation without a 2-week washout
- Regular use of NSAIDs more than 3 days per week in the prior two weeks
- Antibiotic use within 4 weeks prior to enrollment
- Current restrictive or specialty diets like vegan, vegetarian, gluten-free, Paleo, or specific carbohydrate diets
- Gastrointestinal diseases including inflammatory bowel disease, celiac disease, gastrointestinal cancers
- Recent bowel preparation or colonoscopy within 4 weeks
- Gastrointestinal surgeries except cholecystectomy (which must be recorded)
- Use or planned use of GLP-1 receptor agonists or dual GLP-1/GIP receptor agonists for weight management without at least 4 weeks discontinuation
- Use of proton pump inhibitors (PPI) must be recorded with type, dose, and duration
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants will be randomly assigned to consume either a prebiotic or a placebo daily for the first three days and then twice daily for the remaining weeks. After 4 weeks, they will switch to the other product for another 4 weeks. Participants will record their consumption and gastrointestinal symptoms in a daily log and have weekly check-ins with the research coordinator.
Weekly visits for 8 weeks
Trial Site Locations
Total: 1 location
1
Ali Keshavarzian
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
M
Michelle Villanueva, M.S.
L
Lena DiBenedetto, B.S
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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