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Beer belly to brain boost? probiotics and less booze may sharpen aging minds

NCT ID NCT07415707

Knowledge-focused Sponsor: University of Miami Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether a combination of reducing alcohol and taking a probiotic supplement can improve thinking skills and brain metabolism in healthy older adults (ages 65-84) who are heavy drinkers. Twenty participants will receive either a probiotic or a placebo for 30 days, plus a single counseling session to help cut back on drinking. Researchers will measure changes in cognitive test scores and brain glucose levels.

What this could mean

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

Active substance
Probiotic supplement (Visbiome) and behavioral counseling (motivational interviewing)
What this could lead to
If it works, this could point toward a simple way to protect brain function in older adults who drink heavily.
What could go wrong
This is a very small pilot study with only 20 people, so results may not apply widely. The combination approach makes it hard to know which part helps.

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 20 people

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

Started

Feb 2026

Expected to finish

Apr 2027

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

65 to 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Between 65 and 84 years of age * English speaking * Able to provide valid informed consent, understand requirement and risk/benefits of the study and comply with study protocol * Heavy drinker defined as \>14 alcoholic drinks/week for men and \>7 drinks/week for women * Interested in reducing their alcohol consumption Exclusion Criteria: * BMI ≥ 35 * Fasting Glucose \> 125 mg/dL * Current or previously diagnosed with Type 1 or 2 Diabetes * Requires the use of insulin and/or other glucose lowering agents * Unable to fast for 12 hours * Past serious alcohol withdrawal symptoms * MRI Contraindications (e.g., certain devices and implants, claustrophobic) * Diagnosed with a neurodegenerative disease (e.g., Alzheimer's Disease) * Diagnosed with a psychotic disorder * Current substance dependence diagnosis (except for mild or moderate alcohol) * Consumption of over 300 drinks in the past 30 days * Current probiotic use or recent probiotic use within the past 30 days * Current antibiotic use or recent antibiotic use within the past 30 days * In active cancer treatment and/or have advanced cancer * Taking daily steroids and/or immunosuppressants * Lifetime organ or bone marrow transplant; primary immunodeficiency (e.g., DiGeorge syndrome or Wiskott-Aldrich syndrome) or transplant recipient or prescribed immunosuppressant medications * PI's discretion

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Conditions

The condition(s) this trial relates to.

Alcohol Drinking

As listed by the trial registrant

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

Aging Alcohol drinking

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

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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