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.
Age ≥ 18 years old
Willing to consume PFM and/or willing to consume placebo drink, follow instructions of study team and sign consent form
Lactose intolerance or another intolerance that prevents the safe consumption of dairy products
Allergy to any ingredients in the PFM formulations, including almonds/nuts, lactose/dairy, dextrose, artificial sweeteners, or dyes used in flavoring
Known allergy or hypersensitivity to peanuts or soy, as indicated on the pectin product label.
Known allergy, intolerance, or hypersensitivity to Ensure® or any of its components.
Parallel
Probiotic Fermented Milk (PFM) Drink
Dietary supplementA 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 supplementParticipants 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.
Change in Gut Microbiome Shannon Diversity Index
Change in gut microbiome alpha diversity from baseline to Day 30, quantified using the Shannon diversity index derived from whole-genome shotgun metagenomic sequencing of stool samples. A single change value will be calculated for each participant as the Day 30 Shannon diversity index minus the baseline Shannon diversity index. Unit of Measure: Shannon diversity index
Change in Stool Lipocalin-2 Concentration
Change in stool lipocalin-2 concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: ng/g stool
Change in Stool Calprotectin Concentration
Change in stool calprotectin concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: µg/g stool
Change in Serum Monocyte Chemoattractant Protein-1 Concentration
Change in serum monocyte chemoattractant protein-1 (MCP-1) concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: pg/mL
Change in Serum Interleukin-1 Beta Concentration
Change in serum interleukin-1 beta (IL-1β) concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: pg/mL
Change in SF-36 Physical Component Summary Score
Change in the Short Form-36 (SF-36) Physical Component Summary (PCS) score from baseline to Day 30 in caregivers. A single PCS summary score will be calculated at each time point, and the outcome will be the Day 30 PCS score minus the baseline PCS score. The SF-36 Mental Component Summary score is reported as a separate outcome measure. Unit: PCS score
Change in SF-36 Mental Component Summary Score
Change in the Short Form-36 (SF-36) Mental Component Summary (MCS) score from baseline to Day 30 in caregivers. A single MCS summary score will be calculated at each time point, and the outcome will be the Day 30 MCS score minus the baseline MCS score. The SF-36 Physical Component Summary score is reported as a separate outcome measure. Unit: MCS score
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