Exploring the effects of gut microbiota on inflammation in people with HIV and alcohol use disorder

Gut Microbiota-Mediated Inflammatory Interactions Between Alcohol Use Disorders and HIV Infection

This study tests whether taking prebiotics can help reduce inflammation and improve gut health in people with HIV who also struggle with alcohol use disorder.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: Rush University Medical Center (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chicago, IL 60612, Illinois)
• Trial ID: NCT06139224 on ClinicalTrials.gov

What this trial studies

This study investigates the interactions between gut microbiota, inflammation, and the effects of alcohol use disorder (AUD) in individuals living with HIV. It aims to understand how AUD exacerbates inflammation and gut barrier integrity issues in HIV-positive patients. Participants will consume prebiotics for 10 days to assess their potential in enhancing gut barrier function and reducing inflammation. The study includes both HIV-positive individuals on antiretroviral therapy and matched HIV-negative controls to compare outcomes.

Who should consider this trial

Good fit: Ideal candidates are HIV-positive individuals aged 45 to 80 who have been on antiretroviral therapy for at least 12 months and have a stable CD4+ T cell count.

Not a fit: Patients with significant gastrointestinal conditions that could complicate participation or increase risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of inflammation and gut health in patients with HIV and AUD.

How similar studies have performed: While the specific approach of using prebiotics in this context may be novel, preliminary data suggest potential benefits, indicating a promising area of exploration.

Eligibility criteria

Inclusion Criteria:

* HIV+ Group :
* Age 45 to 80 years
* 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 change in ART for at least three months
* CD4+ T cell count of 350 cells/µl
* Plasma HIV-1 RNA level consistently below the limit of detection of commercial ultrasensitive assays for at least six months before study entry.
* Ability and willingness to provide informed consent
* HIV Negative Group:
* Age 45 to 80 years
* Matched to the HIV+ ART-treated group (age (+/- 5 years), gender, ethnicity, sexual orientation, smoking, and body mass index (+/-3)).
* Ability and willingness to provide informed consent

Exclusion criteria:

* Any condition that, in the opinion of the gastrointestinal (GI) specialist, would either be a contraindication to endoscopy or would increase the risk from sedation, endoscopy, or mucosal biopsies. These conditions may include, but are not limited to:
* Significant complication (such as perforation) from prior endoscopy
* Known bleeding diathesis
* Platelet count \< 100,000 per µl
* INR \> 1.3
* Current use of antiplatelet agents (aspirin, other NSAIDs, clopidogrel (PlavixÒ), other antiplatelet agents) or anticoagulants (heparin, low molecular weight heparin, warfarin, lepirudin, or other anticoagulants) and inability to temporarily hold such medications for endoscopy.
* Decompensated disease (e.g., active angina, unstable angina, or MI within two months, congestive heart failure, renal failure and dialysis, respiratory insufficiency with FEV1 \< 1L or oxygen dependence, cirrhosis, uncontrolled diabetes)
* Ongoing substance abuse
* Receipt of a non-HIV vaccine within 30 days
* Opportunistic infection within 60 days
* Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 60 days
* Alcoholism including binging
* history of clinically significant medical disease, includes 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%).
* Regular use of NSAIDs (daily more than three days a week during the prior two weeks of starting the study)
* Antibiotic use during prior four weeks to the colonoscopy).
* Abnormal blood clotting time (e.g., prolonged PT) or use of anticoagulant during 3-7 days prior to colonoscopy that would preclude biopsy sample collection.
* Obesity (BMI\>30 because it can affect the microbiota community.
* Use of special diet like vegan, vegetarian, gluten-free, Paleo, specific carbohydrate diet because these diets can impact the microbiota community.
* Inflammatory bowel disease.
* Celiac disease.
* GI cancers
* gastrointestinal surgeries/resection
* Inability to sign an informed consent form.

Where this trial is running

Chicago, IL 60612, Illinois

• Ali Keshavarzian — Chicago, IL 60612, Illinois, United States (RECRUITING)

Study contacts

• Study coordinator: Michelle Villanueva, M.S.

Conditions: Alcohol Use Disorder, Human Immunodeficiency Virus