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Gut Microbiota and Inflammation in HIV and Alcohol Use Disorder

This study is looking at how the gut (digestive system) and its bacteria (microbiota) are affected by both Alcohol Use Disorder (AUD) and HIV infection, and how this might lead to inflammation. Researchers believe that the combination of AUD and HIV can worsen inflammation by affecting the gut lining. You might be able to join if you are 21-75 years old, have HIV-1 and have been on stable antiretroviral therapy (ART) for at least 6 months. Participants will take either a prebiotic or a placebo (an inactive substance like maltodextrin) for 4 weeks, then switch to the other for another 4 weeks. The main goal is to see how these interventions affect your intestinal permeability (how easily substances pass through your gut lining) after 8 weeks. The study is currently recruiting 40 participants.

Study design
This is an interventional study with 40 planned participants. It uses a crossover design where participants will be randomly assigned to take either a prebiotic or a placebo first, then switch to the other, and both you and the research team will not know which you are taking (blinded).
What's involved
You would consume either a prebiotic or a placebo daily for 4 weeks, then switch to the other for another 4 weeks. A sugar test for intestinal permeability will be conducted at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your intestinal permeability will be measured at 8 weeks, after you have completed both the prebiotic and placebo consumption periods.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06139224

Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Recruiting
NAAges 45–75InterventionalBasic science
Rush University Medical Center
~40 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:4 week prebiotic consumption4 week placebo consumption

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy
Measured over 8 weeks

Conditions

Alcohol Use Disorder
Human Immunodeficiency Virus

Explore related trials

Alcohol use disorderHIV Infection

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Michelle Villanueva, M.S.
[email protected]
312-942-8927
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
CD4+ T cell count of \> 250 cells/µl, nadir CD4+ T cell count of \> 250 cells/µl
Plasma HIV-1 RNA level consistently below the limit of detection of commercial ultrasensitive assay (usually \<20 copies/mL) for at least six months before study entry.
For those for "AUD group" AUDIT-C =/\> 4 for men and = ≥3 for women.
Documented BMI between 25-40
Ability and willingness to provide informed consent

Exclusion

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%).
Fiber intake \> 15 grams.
Chronic HBV and un-treated HCV (documentation of cure can be enrolled)
Herbal/botanical supplements with potential microbiome or anti-inflammatory effects (e.g., inulin/chicory fiber, berberine, high-dose polyphenols). Participants will be eligible to participant if they discontinue use for at least 2 weeks before enrollment.
Regular use of medications that affect intestinal permeability including NSAIDs (daily more than three days a week during the prior two weeks). Type and frequency and duration of NSAID (those taking less than 3 /per week) should be recorded. If participants need to take antibiotics or NSAIDS during the study, duration, name, and dosage will be recorded but they will not be excluded.
Antibiotics (during or prior) four weeks to enrollment. Type and duration of antibiotic treatment within 90 days should be recorded.
Current use of a restrictive or specialty diet like vegan, vegetarian, gluten-free, Paleo, or any specific carbohydrate diet because these diets can impact the microbiota community.
Use of herbal, botanical, or nutraceutical supplements with potential effects on the gut microbiome or systemic inflammation. This includes:
Have undergone bowel preparation or colonic (e.g., for a colonoscopy or similar procedure) for example, within 4 weeks prior to enrollment.
Gastrointestinal surgeries/resection (cholecystectomy is accepted but should be recorded)
Currently taking or planning to start a GLP-1 receptor agonist or dual GLP-1/GIP receptor agonist for weight loss or weight management. This includes medications such as semaglutide (Ozempic, Wegovy, Rybelsus), liraglutide (Victoza, Saxenda), dulaglutide (Trulicity), exenatide (Byetta, Bydureon), lixisenatide (Adlyxin), and tirzepatide (Mounjaro, Zepbound). Participants who previously used these medications may be eligible if they discontinued use at least 4 weeks prior to enrollment. For eligible individuals, the medication name, dosage, frequency, route of administration (for example injection or oral), and date of last dose will be documented at enrollment. The study team will document the last dose to verify that a sufficient wash out period has occurred before enrollment and to account for any possible microbiome differences.
Use of PPI is accepted but type, dose and duration should be recorded.

What this trial measures

  • Sugar test for intestinal permeability after prebiotic and placebo consumption in substudy8 weeks

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