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

NCT07800195 | Not Yet Recruiting

• 2 other identifiers: Study00784525A01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caregivers; Probiotic fermented milk; Gut microbiome; Gut-brain axis; Microbiome diversity; Nutrient absorption; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and Day 30

Secondary Outcomes (19)

• Change in Stool Lipocalin-2 Concentration

  Baseline and Day 30

• Change in Stool Calprotectin Concentration

  Baseline and Day 30

• Change in Serum Monocyte Chemoattractant Protein-1 Concentration

  Baseline and Day 30

• Change in Serum Interleukin-1 Beta Concentration

  Baseline and Day 30

• Change in Serum Tumor Necrosis Factor-Alpha Concentration

  Baseline and Day 30

Other Outcomes (2)

• Change in SF-36 Physical Component Summary Score

  Baseline and Day 30

• Change in SF-36 Mental Component Summary Score

  Baseline and Day 30

Study Arms (2)

Probiotics fermented milk

EXPERIMENTAL

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

Placebo milk

PLACEBO COMPARATOR

ADRD and caregivers

Dietary Supplement: Probiotic Fermented Milk (PFM) Drink; Dietary Supplement: Placebo

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 milk; Probiotics fermented milk

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.

Placebo milk; Probiotics fermented milk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Willing to consume PFM and/or willing to consume placebo drink, follow instructions of study team and sign consent form

You may not qualify if:

• 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.
• Cancer patients receiving chemotherapy, due to potential increased risk of infection from GI tract damage
• Participants who require systemic antibiotics after randomization will have the antibiotic use documented and will be withdrawn due to potential effects on the gut microbiome. Data collected prior to antibiotic use may be retained, and withdrawn participants will be replaced to maintain the target sample size.
• Major surgery(ies) of the gut or brain within the past five years
• Diagnosis of inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, acid reflux, gastroesophageal reflux disease (GERD), Clostridium difficile infection (CDI), or any other gastrointestinal disease that could significantly change the microbiome History of fecal microbiota transplantation
• Small intestinal bacterial overgrowth
• History of anticipatory nausea, vomiting, constipation, or diarrhea
• 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
• Critical or terminal illnesses including diabetes
• Pregnant women will be excluded from the study based on self-report during the screening process. No pregnancy testing kits will be provided, and pregnancy testing will not be performed as part of this study. Therefore, individuals who are currently pregnant are excluded from participation.
• Significant mental health conditions

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Center for Microbiome Research, Microbiomes Institute, University of South Florida, Tampa, FL, 33620

Tampa, Florida, 33612, United States

Location

Related Publications (16)

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MeSH Terms

Interventions

Melanocyte-Stimulating Hormones

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Shalini Jain, PhD

CONTACT

813-9746281; jains10@usf.edu

Hariom Yadav, PhD

CONTACT

8139748222; hyadav@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, randomized, placebo-controlled clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ADRD and caregivers

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)