MedTrace Logo

Probiotic Milk Drink for Gut and Brain Health in Older Adults and Caregivers

NCT07800195 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-09-02

No results posted yet for this study

Summary

This double-blind, randomized, placebo-controlled clinical trial will evaluate the effects of a probiotic fermented milk (PFM) drink on gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers. Up to 40 participants will be enrolled.

Participants will be randomly assigned to consume either the PFM drink or a matched placebo daily for 30 days. The primary objective is to determine whether PFM consumption improves gut microbiome abnormalities. Secondary objectives include evaluating effects on nutrient absorption, gut microbiome diversity and composition, and systemic inflammation. The study will also explore relationships between changes in nutrient absorption, microbiome profiles, inflammation, and behavioral outcomes in participants with ADRD and their caregivers.

Each participant will participate in the study for approximately 30 days. This pilot study is intended to generate preliminary clinical and biological data regarding the potential role of probiotic nutrition in supporting gut and brain health and to inform the design of future larger clinical trials.

Conditions

  • Alzheimer Disease Related Dementia

Interventions

DIETARY_SUPPLEMENT

Probiotic Fermented Milk (PFM) Drink

A human-origin probiotic fermented milk (PFM) drink has been developed for this clinical study. Over 1,000 human-derived probiotic strains were screened for gut and brain health effects using C. elegans, identifying 36 promising strains. These were further evaluated for growth in milk, fermentation capacity (pH reduction and coagulation), and effects on healthspan. Four strains with strong performance were selected: Limosilactobacillus reuteri HL278, Lactiplantibacillus plantarum HL279, Lacticaseibacillus paracasei HL260, and Lactiplantibacillus plantarum HL82. A multi-strain formulation was produced in a dedicated facility. The final PFM contains GRAS-designated probiotic strains and is manufactured for research use only in this study.

DIETARY_SUPPLEMENT

Placebo

Participants will receive two 4-ounce servings of a placebo drink daily for 30 days. The placebo drink is matched in taste, appearance, and volume but does not contain active probiotic components.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-10-01
Completion
2026-10-20

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800195 on ClinicalTrials.gov