+1 877 705 1914• 24 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 45Years - 75Years
All Genders
Healthy Volunteers
ID06139224

Study of Prebiotic Effects on Gut Inflammation in People Living with HIV and Alcohol Use Disorder

Led by Rush University Medical Center · Updated on 2026-06-04

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

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

Research Team

M

Michelle Villanueva, M.S.

L

Lena DiBenedetto, B.S

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here