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

Eligibility criteria

Inclusion Criteria:• Diagnosed with ADRD and accompanied with their caregiver
* Age ≥ 18 years old
* Willing to consume PFM and/or willing to consume placebo drink, follow instructions of study team and sign consent form
Exclusion Criteria:
* 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* Participants who require systemic antibiotics after randomization will have the antibiotic use documented and will be withdrawn due to potential effects on the gut microbiome. Data collected prior to antibiotic use may be retained, and withdrawn participants will be replaced to maintain the target sample size.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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-09-02