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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 30 days
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be randomly assigned to consume either the PFM drink or a matched placebo daily for 30 days."
- "Each participant will participate in the study for approximately 30 days."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a fermented milk drink with probiotics (helpful bacteria) may support gut and brain health in people with Alzheimer's disease or related dementias and their caregivers. Participants are assigned by chance to drink either the probiotic drink or a similar drink without probiotics each day for 30 days.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Alzheimer's disease or a related dementia and be joined by your caregiver.
- Be at least 18 years old.
- Be willing to drink the assigned study drink, follow the study team's directions, and sign a consent form.
Who can't join
- Cannot safely have dairy, or have an allergy or intolerance to study drink ingredients or Ensure. Listed ingredients include almonds or other nuts, dairy, lactose (milk sugar), dextrose (a sugar), artificial sweeteners, flavoring dyes, peanuts, and soy.
- Are receiving chemotherapy for cancer, or have a critical or terminal illness, including diabetes.
- Used antibiotics, probiotics, or 3 servings of yogurt a day in the past 30 days. Probiotic use means at least 100 million CFU (a measure of live bacteria) per day. People who need antibiotics that work throughout the body after group assignment must leave the study.
- Had major gut or brain surgery in the past 5 years.
- Have a gut disease that could greatly change gut bacteria, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, acid reflux, or C. difficile infection. Also excluded: too much bacteria in the small intestine or a past stool transplant.
- Have a history of nausea before an expected event, vomiting, constipation, or diarrhea.
- Are pregnant.
- Have a significant mental health condition.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
FL
- Center for Microbiome Research, Microbiomes Institute, University of South Florida, Tampa, FL, 33620 · Tampa, FL 33612Shalini Jain, PhD · Study contact · 813-9746281 · jains10@usf.eduDhananjay Yadav, PhD · Study contact · 8134521781 · dhananjay11@usf.eduHariom Yadav, PhD · Principal investigatorShalini Jain, PhD · Principal investigatorMore trials in Tampa