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

Conditions

• Alzheimer Disease Related Dementia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Probiotic Fermented Milk (PFM) Drink — DIETARY_SUPPLEMENT
  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.
• Placebo — DIETARY_SUPPLEMENT
  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.

Study Details

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.

Key Dates

First listed

Sep 2, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Oct 1, 2026

Completion

Oct 20, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Probiotics fermented milk
  Participants will receive two 4-ounce servings of a probiotic fermented milk (PFM) drink daily for 30 days. The PFM drink contains probiotic strains intended to support gut microbiome balance, nutrient absorption, and gut-brain health. 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.
• Placebo Comparator: Placebo milk
  ADRD and caregivers

Primary Outcome Measure

Change in Gut Microbiome Shannon Diversity Index [ Time Frame: Baseline and Day 30 ]

Central Contacts

• Shalini Jain, PhD
  813-9746281
  [email protected]
• Hariom Yadav, PhD
  8139748222
  [email protected]

Locations (1)

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