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Prebiotics for AUD and HIV/AIDS

N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV+ Group: Infection with HIV-1, as documented by a licensed ELISA and confirmed by a Western blot or HIV-1 RNA
HIV+ Group: On ART for at least 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights

Study Summary

This trial is studying the effects of alcohol use disorder and HIV on gut health, inflammation, and brain health. It will test whether a prebiotic intervention can help reduce inflammation and improve gut health in HIV+ people with/without AUD.

Who is the study for?
This trial is for people aged 45-70 with HIV on ART therapy for at least a year, with stable treatment and undetectable viral load for six months. It's also open to HIV-negative individuals matching the same age, lifestyle, and health criteria. Excluded are those with certain medical conditions or risks related to endoscopy, substance abuse issues, recent vaccines or infections, immunosuppressive treatments, alcoholism including binging behavior.Check my eligibility
What is being tested?
The study tests if prebiotics can improve gut health and reduce inflammation in people living with HIV who may also have an alcohol use disorder (AUD). Participants will consume prebiotics for ten days and provide stool samples and blood draws during two visits. The larger study includes both HIV-positive/negative groups with/without AUD to compare intestinal resilience against alcohol-induced damage.See study design
What are the potential side effects?
Prebiotics are generally safe but could potentially cause digestive discomfort such as bloating or gas. Since this is an observational study focusing on dietary intervention rather than medication, severe side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am HIV positive, confirmed by tests.
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I have been on HIV treatment for at least a year.
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I am HIV positive and my HIV treatment has been stable for the last three months.
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I am between 45 and 70 years old and do not have HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sugar test for intestinal permeability after prebiotic consumption in substudy
Secondary outcome measures
Change in plasma and stool SCFA level before and after prebiotic treatment
Change in stool and intestinal microbiota composition after prebiotic consumption

Trial Design

2Treatment groups
Experimental Treatment
Group I: HIV-infected ART-suppressed individuals with no AUDExperimental Treatment1 Intervention
Only 10 HIV+ ART+,AUD - individuals will be invited to take part in a prebiotic sub study, which they will take a commercially available prebiotic (FOS) for 10 days
Group II: HIV-infected ART-suppressed individuals with AUDExperimental Treatment1 Intervention
Only 10 HIV+ ART+,AUD + individuals will be invited to take part in a prebiotic sub study, which they will take a commercially available prebiotic (FOS) for 10 days

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,481 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the criteria to join this medical research?

"Aspiring participants in this medical study must meet certain criteria, such as being between the ages of 45 and 70 years old with a diagnosis of alcoholism. Currently, around 20 patients are needed for enrollment."

Answered by AI

Is the minimum age requirement for participation in this study above 18 years?

"This clinical trial has an age limit of 45-70. Therefore, potential participants must meet the minimum and maximum thresholds to be considered eligible for enrollment."

Answered by AI

Is the recruitment process underway for this experiment?

"According to the details on clinicaltrials.gov, this particular medical inquiry is not currently recruiting any further participants. Its posting date was November 28th 2023 and its most recent update occurred 14 days later. Nonetheless, there are still 999 other trials that require volunteers at present."

Answered by AI

Who else is applying?

What site did they apply to?
Ali Keshavarzian
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection
Ali Keshavarzian 2024. "Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139224.
~13 spots leftby Sep 2024
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