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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

Must not have

Gastrointestinal surgeries/resection

Inability to sign an informed consent form

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my digestive system.

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I am unable to sign a consent form.

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I am currently using blood thinners and cannot stop them for a procedure.

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I had a serious problem from a previous camera test.

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I have a bleeding disorder.

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I have celiac disease.

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I do not have severe heart, lung, kidney, liver problems, or uncontrolled diabetes.

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I have not had an opportunistic infection in the last 60 days.

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I do not have severe kidney, liver, heart problems, or uncontrolled diabetes.

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I have been diagnosed with inflammatory bowel disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sugar test for intestinal permeability after prebiotic consumption in substudy

Secondary study objectives

Change in plasma and stool SCFA level before and after prebiotic treatment

Change in stool and intestinal microbiota composition after prebiotic consumption

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 14Eligibility criteria met