NCT07415707

Brief Summary

The goal of this pilot study is to explore a combination of two interventions: (1) a behavioral alcohol-reduction intervention using motivational interviewing, and (2) a blinded probiotic microbiome or placebo intervention. The study examines whether these interventions improve cognitive and neurophysiological function, including brain metabolism, in older adults who are high-risk alcohol drinkers.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Apr 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

January 22, 2026

Last Update Submit

March 3, 2026

Conditions

AgingAlcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • Change in Total Cognition Composite score

    Cognitive performance will be assessed using the NIH Toolbox Cognition Battery v3 to measure the Total Cognition Composite score at two time-points and examined for change within subjects.

    Baseline, 30 days

  • Change in Brain Metabolism

    Brain metabolism will be assessed using magnetic resonance spectroscopy (MRS) to quantify glucose uptake.

    Baseline, 30 days

Study Arms (2)

Motivational Interviewing + Probiotic

EXPERIMENTAL

Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive an active probiotic supplement 900 billion colony forming units (CFU), once daily.

Dietary Supplement: VisbiomeBehavioral: Motivational Interviewing

Motivational Interviewing + Placebo

PLACEBO COMPARATOR

Participants in this arm will be given a brief motivational interview to promote drinking reduction. During the 30-day intervention, participants will receive a placebo supplement once daily.

Behavioral: Motivational InterviewingOther: Placebo

Interventions

VisbiomeDIETARY_SUPPLEMENT

Participants will receive 900 billion Colony Forming Units (CFU) once daily for 30 days

Motivational Interviewing + Probiotic
Motivational InterviewingBEHAVIORAL

Participants will receive one counseling session at baseline via video call, lasting up to 30 minutes

Motivational Interviewing + PlaceboMotivational Interviewing + Probiotic
PlaceboOTHER

Participants will receive a standard placebo designed to resemble the probiotic once daily for 30 days

Motivational Interviewing + Placebo

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Teddy Salan, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teddy Salan, PhD

CONTACT

305-243-9228txs785@med.miami.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 17, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)