Recruiting

Motivational Interviewing & Probiotic

Sponsor:

University of Miami

Code:

NCT07415707

Conditions

Aging

Alcohol Drinking

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

Visbiome

Motivational Interviewing

Placebo

Study Details

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.

Conditions

Aging

Alcohol Drinking

Study ID

NCT07415707

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Motivational Interviewing + Probiotic

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.

placebo comparator: Motivational Interviewing + Placebo

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.

Interventions

Visbiome

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

Motivational Interviewing

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

Placebo

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

Primary outcome measure

  • Change in Total Cognition Composite score [ Time Frame: Baseline, 30 days ]
  • Change in Brain Metabolism [ Time Frame: Baseline, 30 days ]

Central Contacts and Locations

Central contacts

Teddy Salan, PhD

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

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Teddy Salan, PhD

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

Principal Investigator:

Teddy Salan, PhD

More Information

Sponsor

University of Miami

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-04.