NCT07800195Not yet recruiting
Probiotic Milk Drink for Gut and Brain Health in Older Adults and Caregivers
A Novel Probiotic Fermented Milk Drink to Improve Gut and Brain Health in Older Floridians and Their Caregivers
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Mar 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- University of South Florida
- Diseases
- Alzheimer disease
- NCT number
- NCT07800195
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Sept 2026 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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- Participants who require systemic antibiotics after randomization will have the antibiotic use documented and will be withdrawn due to potential effects on the gut microbiome.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
Other illness
- 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.
- 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
- History of anticipatory nausea, vomiting, constipation, or diarrhea
- Critical or terminal illnesses including diabetes
- Significant mental health conditions
Other
- Lactose intolerance or another intolerance that prevents the safe consumption of dairy products
- Small intestinal bacterial overgrowth
- 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
- 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.
Who the study is looking for
- Age ≥ 18 years old
- Willing to consume PFM and/or willing to consume placebo drink, follow instructions of study team and sign consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Microbiome Research, Microbiomes Institute, University of South Florida, Tampa, FL, 33620 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.