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Could a prebiotic soothe the gut in HIV and alcohol use?

NCT ID NCT06139224

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether a prebiotic supplement can help repair the gut barrier and reduce inflammation in people with HIV who also have alcohol use disorder. Forty participants will take either a prebiotic or a placebo for four weeks, then switch. Researchers will measure gut health, inflammation, and immune markers to understand the link between gut bacteria and HIV-related complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prebiotic (short-chain fatty acid prebiotic powder)
What this could lead to
If successful, this could point toward a simple dietary supplement to reduce inflammation and improve gut health in people living with HIV.
What could go wrong
This is a small, early proof-of-concept study (40 people) with a short 8-week duration. Results may not apply to broader populations or lead to a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 criteria: * 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: prebiotic fibers such as inulin, chicory root, fructooligosaccharides (FOS), or galactooligosaccharides (GOS) botanical or herbal compounds with microbiome-modulating or anti-inflammatory properties, such as berberine, curcumin, resveratrol, or high-dose polyphenol Probiotics or synbiotics Digestive enzymes or other nutraceuticals reported to alter gut microbial composition. Potential participants may enroll if they discontinue use for at least 2 weeks before enrollment. Type, dosage, frequency, route of administration (for example oral), and date last taken will be documented at time of enrollment verify that a sufficient washout period has occurred before enrollment. -Have undergone bowel preparation or colonic (e.g., for a colonoscopy or similar procedure) for example, within 4 weeks prior to enrollment. Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease). Celiac disease. GI cancers * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Ali Keshavarzian

    RECRUITING

    Chicago, Illinois, 60612, United States

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