An interventional study of Probiotic Fermented Milk (PFM) Drink and Placebo in Alzheimer Disease Related Dementia, sponsored by University of South Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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.
This pilot clinical trial will investigate the effects of a human-origin probiotic fermented milk (PFM) beverage on biological pathways related to gut and brain health in individuals with Alzheimer's disease and related dementias (ADRD) and their caregivers. The study is based on evidence suggesting that alterations in the gut microbiome, nutrient metabolism, and systemic inflammation may be associated with cognitive and behavioral health and may represent modifiable targets in ADRD.
Participants with ADRD and their caregivers will be enrolled as patient-caregiver dyads and independently randomized to receive either the PFM intervention or a matched placebo for 30 days. The PFM contains four human-origin probiotic strains: Limosilactobacillus reuteri HL278, Lactiplantibacillus plantarum HL279, Lacticaseibacillus paracasei HL260, and Lactiplantibacillus plantarum HL82.
Biological assessments will be performed before and after the intervention to characterize changes in the gut microbiome, nutrient-related measures, and systemic inflammation. Fecal microbiome composition will be evaluated using metagenomic sequencing and bioinformatics approaches to examine microbial diversity and taxonomic composition. Blood- and stool-based laboratory analyses will be used to assess selected nutrient and inflammatory biomarkers.
Clinical and behavioral measures will also be evaluated to explore whether biological changes associated with the intervention are related to measures of health, quality of life, agitation, stress, or anxiety in participants with ADRD and their caregivers. Analyses will compare changes between the PFM and placebo groups and explore relationships among microbiome characteristics, nutrient-related measures, inflammatory markers, and behavioral outcomes.
The study is intended to generate preliminary information regarding the biological effects and feasibility of the PFM intervention and to provide data that may inform the design of larger future clinical trials.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:• Diagnosed with ADRD and accompanied with their caregiver
Exclusion Criteria:
Antibiotic or probiotic or heavy yogurt (3 servings per day) use within the past 30 days
o Probiotic use is defined as consumption of ≥108 CFU/day, in the form of tablets, capsules, lozenges, powders, or dairy products in which probiotics are a major ingredient
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Probiotic Fermented Milk (PFM) Drink · Dietary Supplement: Placebo
ADRD and caregivers
Dietary Supplement: Probiotic Fermented Milk (PFM) Drink · Dietary Supplement: Placebo
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.
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.
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
Time frame: Baseline and Day 30
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
Time frame: Baseline and Day 30
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
Time frame: Baseline and Day 30
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
Time frame: Baseline and Day 30
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
Time frame: Baseline and Day 30
Change in Serum Tumor Necrosis Factor-Alpha Concentration
Change in serum tumor necrosis factor-alpha (TNF-α) concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: pg/mL
Time frame: Baseline and Day 30
Change in Serum Interleukin-6 Concentration
Change in serum interleukin-6 (IL-6) concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: pg/mL
Time frame: Baseline and Day 30
Change in Serum C-Reactive Protein Concentration
Change in serum C-reactive protein (CRP) concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: µg/mL
Time frame: Baseline and Day 30
Change in Serum Zinc Concentration
Change in serum zinc concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: µg/dL
Time frame: Baseline and Day 30
Change in Serum Iodine Concentration
Change in serum iodine concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: µg/dL
Time frame: Baseline and Day 30
Change in Serum Magnesium Concentration
Change in serum magnesium concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: mg/dL
Time frame: Baseline and Day 30
Change in Serum Folate Concentration
Change in serum folate concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: ng/mL
Time frame: Baseline and Day 30
Change in Serum Vitamin D3 Concentration
Change in serum vitamin D3 concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: ng/mL
Time frame: Baseline and Day 30
Change in Serum Vitamin B12 Concentration
Change in serum vitamin B12 concentration from baseline to Day 30, calculated as the Day 30 value minus the baseline value. Unit: pg/mL
Time frame: Baseline and Day 30
Gut Microbiome Beta Diversity Assessed by Bray-Curtis Dissimilarity
Gut microbial community composition will be assessed at baseline and Day 30 using Bray-Curtis dissimilarity calculated from stool metagenomic sequencing data. Bray-Curtis dissimilarity will be used to evaluate differences in microbial community composition between intervention groups and study time points. Unit of Measure: Bray-Curtis dissimilarity
Time frame: Baseline and Day 30
Change in EQ-5D Index Score in ADRD Participants
Change in EuroQoL-5D (EQ-5D) health utility index score from baseline to Day 30 in participants with ADRD. Responses across the EQ-5D health dimensions will be converted to a single health utility index score according to the instrument scoring procedure. The outcome will be the Day 30 index score minus the baseline index score. Unit: EQ-5D index score
Time frame: Baseline and Day 30
Change in Cohen-Mansfield Agitation Inventory Total Score
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline to Day 30 in participants with ADRD. Responses to individual CMAI items will be combined according to the instrument scoring procedure to generate one total agitation score at each time point. The outcome will be the Day 30 total score minus the baseline total score. Unit: CMAI total score
Time frame: Baseline and Day 30
Change in Perceived Stress Scale Total Score in Caregivers
Description: Change in Perceived Stress Scale (PSS) total score from baseline to Day 30 in caregivers. Individual PSS item responses will be combined according to the instrument scoring procedure to generate one total perceived stress score at each time point. The outcome will be the Day 30 total score minus the baseline total score. Unit: PSS total score
Time frame: Baseline and Day 30
Change in State-Trait Anxiety Inventory State Anxiety Score
Description: Change in the State-Trait Anxiety Inventory (STAI) State Anxiety score from baseline to Day 30 in caregivers. Responses to the State Anxiety items will be combined according to the instrument scoring procedure to generate one State Anxiety score at each time point. The outcome will be the Day 30 score minus the baseline score. Unit: STAI State Anxiety score
Time frame: Baseline and Day 30
Change in State-Trait Anxiety Inventory Trait Anxiety Score
Description: Change in the State-Trait Anxiety Inventory (STAI) Trait Anxiety score from baseline to Day 30 in caregivers. Responses to the Trait Anxiety items will be combined according to the instrument scoring procedure to generate one Trait Anxiety score at each time point. The outcome will be the Day 30 score minus the baseline score. Unit: STAI Trait Anxiety score
Time frame: Baseline and Day 30
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
Time frame: Baseline and Day 30
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
Time frame: Baseline and Day 30
Plan to share: No — We are conducting a small (n=24), likely enrollment (n=40) single-site pilot/clinical study. Data involves older adults and ADRD patients + caregivers (sensitive population)
Start is estimated for Sep 2026; primary completion for Oct 2026, 1 month later.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 1 month is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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