Alzheimer Disease Related DementiaPFMNCT07800195
Probiotic Milk Drink for Gut and Brain Health in Older Adults and Caregivers
A study testing Probiotic Fermented Milk (PFM) Drink in people with Alzheimer Disease Related Dementia, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease Related Dementia
- What is being tested?
- Probiotic Fermented Milk (PFM) Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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- Participants who require systemic antibiotics after randomization will have the antibiotic use documented and will be withdrawn due to potential effects on the gut microbiome. Data collected prior to antibiotic use may be retained, and withdrawn participants will be replaced to maintain the target sample size.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Center for Microbiome Research, Microbiomes Institute, University of South Florida, Tampa, FL, 33620
Tampa, Florida, 33612
Shalini Jain, PhD, 813-9746281, jains10@usf.edu
Dhananjay Yadav, PhD, 8134521781, dhananjay11@usf.edu
About this study
Official title: A Novel Probiotic Fermented Milk Drink to Improve Gut and Brain Health in Older Floridians and Their Caregivers
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.
Read the detailed description
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.
- Conditions
- Alzheimer Disease Related Dementia
- Being tested
- Probiotic Fermented Milk (PFM) Drink, Placebo
- Keywords
- caregivers, Probiotic fermented milk, Gut microbiome, Gut-brain axis, Microbiome diversity, Nutrient absorption, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Fermented Milk (PFM) DrinkDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotic Fermented Milk (PFM) Drink; Dietary Supplement: Placebo |
| Placebo milk | Placebo comparator | ADRD and caregivers Receives: Dietary Supplement: Probiotic Fermented Milk (PFM) Drink; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Day 30
Secondary outcomes (19)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease Related DementiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ADRD and caregivers
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800195
- Sponsor's protocol ID
- Study007845
- Other IDs
- 25A01
- Acronym
- PFM
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Publications
Ullrich V. Cytochrome P450 and biological hydroxylation reactions. Top Curr Chem. 1979;83:67-104. doi: 10.1007/BFb0019663. No abstract available.
PubMed 384602Ekinci GN, Sanlier N. The relationship between nutrition and depression in the life process: A mini-review. Exp Gerontol. 2023 Feb;172:112072. doi: 10.1016/j.exger.2022.112072. Epub 2022 Dec 21.
PubMed 36565729Covello C, Becherucci G, Di Vincenzo F, Del Gaudio A, Pizzoferrato M, Cammarota G, Gasbarrini A, Scaldaferri F, Mentella MC. Parenteral Nutrition, Inflammatory Bowel Disease, and Gut Barrier: An Intricate Plot. Nutrients. 2024 Jul 17;16(14):2288. doi: 10.3390/nu16142288.
PubMed 39064731Roth-Walter F, Berni Canani R, O'Mahony L, Peroni D, Sokolowska M, Vassilopoulou E, Venter C. Nutrition in chronic inflammatory conditions: Bypassing the mucosal block for micronutrients. Allergy. 2024 Feb;79(2):353-383. doi: 10.1111/all.15972. Epub 2023 Dec 12.
PubMed 38084827Yassine HN, Self W, Kerman BE, Santoni G, Navalpur Shanmugam N, Abdullah L, Golden LR, Fonteh AN, Harrington MG, Graff J, Gibson GE, Kalaria R, Luchsinger JA, Feldman HH, Swerdlow RH, Johnson LA, Albensi BC, Zlokovic BV, Tanzi R, Cunnane S, Samieri C, Scarmeas N, Bowman GL. Nutritional metabolism and cerebral bioenergetics in Alzheimer's disease and related dementias. Alzheimers Dement. 2023 Mar;19(3):1041-1066. doi: 10.1002/alz.12845. Epub 2022 Dec 8.
PubMed 36479795Puga F, Wang D, Rafford M, Poe A, Pickering CEZ. The relationship between daily stressors, social support, depression and anxiety among dementia family caregivers: a micro-longitudinal study. Aging Ment Health. 2023 Jul-Aug;27(7):1291-1299. doi: 10.1080/13607863.2022.2116392. Epub 2022 Aug 29.
PubMed 36038530Culberson JW, Kopel J, Sehar U, Reddy PH. Urgent needs of caregiving in ageing populations with Alzheimer's disease and other chronic conditions: Support our loved ones. Ageing Res Rev. 2023 Sep;90:102001. doi: 10.1016/j.arr.2023.102001. Epub 2023 Jul 5.
PubMed 37414157Chen Y, Gao X, Sun F. Perceived Threat of Alzheimer's Disease and Related Dementias Among Chinese Family Caregivers of Older Adults with Cognitive Impairment. J Gerontol Soc Work. 2024 Oct;67(7):976-994. doi: 10.1080/01634372.2024.2339984. Epub 2024 Apr 8.
PubMed 38590188Kivimaki M, Livingston G, Singh-Manoux A, Mars N, Lindbohm JV, Pentti J, Nyberg ST, Pirinen M, Anderson EL, Hingorani AD, Sipila PN. Estimating Dementia Risk Using Multifactorial Prediction Models. JAMA Netw Open. 2023 Jun 1;6(6):e2318132. doi: 10.1001/jamanetworkopen.2023.18132.
PubMed 37310738Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
PubMed 29051531Zhao L, Guan L, Sun J, Li X. Serum levels of folate, vitamin B6, and vitamin B12 are associated with cognitive impairments in depression patients. Acta Neuropsychiatr. 2024 Feb;36(1):44-50. doi: 10.1017/neu.2023.41. Epub 2023 Aug 29.
PubMed 37642170Nagpal R, Neth BJ, Wang S, Craft S, Yadav H. Modified Mediterranean-ketogenic diet modulates gut microbiome and short-chain fatty acids in association with Alzheimer's disease markers in subjects with mild cognitive impairment. EBioMedicine. 2019 Sep;47:529-542. doi: 10.1016/j.ebiom.2019.08.032. Epub 2019 Aug 30.
PubMed 31477562Chaudhari DS, Jain S, Yata VK, Mishra SP, Kumar A, Fraser A, Kociolek J, Dangiolo M, Smith A, Golden A, Masternak MM, Holland P, Agronin M, White-Williams C, Arikawa AY, Labyak CA, Yadav H. Unique trans-kingdom microbiome structural and functional signatures predict cognitive decline in older adults. Geroscience. 2023 Oct;45(5):2819-2834. doi: 10.1007/s11357-023-00799-1. Epub 2023 May 22.
PubMed 37213047Goto Y, Morita K, Suematsu M, Imaizumi T, Suzuki Y. Caregiver Burdens, Health Risks, Coping and Interventions among Caregivers of Dementia Patients: A Review of the Literature. Intern Med. 2023 Nov 15;62(22):3277-3282. doi: 10.2169/internalmedicine.0911-22. Epub 2023 Mar 1.
PubMed 36858522Rawat P, Sehar U, Bisht J, Reddy AP, Reddy PH. Alzheimer's disease and Alzheimer's disease-related dementias in Hispanics: Identifying influential factors and supporting caregivers. Ageing Res Rev. 2024 Jan;93:102178. doi: 10.1016/j.arr.2023.102178. Epub 2023 Dec 27.
PubMed 38154509
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Probiotic Fermented Milk Drink to Improve Gut and Brain Health in Older Floridians and Their Caregivers
- ClinicalTrials.gov ID
- NCT07800195
- Acronym / sponsor ID
- PFM / Study007845
- Conditions
- Alzheimer Disease Related Dementia
- Keywords
- caregivers, Probiotic fermented milk, Gut microbiome, Gut-brain axis, Microbiome diversity, Nutrient absorption, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- ADRD and caregivers
| Arm | Type | Receives |
|---|---|---|
| Probiotics fermented milk | Experimental | Dietary Supplement: Probiotic Fermented Milk (PFM) Drink, Dietary Supplement: PlaceboParticipants 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. |
| Placebo milk | Placebo comparator | Dietary Supplement: Probiotic Fermented Milk (PFM) Drink, Dietary Supplement: PlaceboADRD and caregivers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Fermented Milk (PFM) DrinkA 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. | Dietary supplement | Placebo milk, Probiotics fermented milk |
| PlaceboParticipants 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 | Placebo milk, Probiotics fermented milk |
Primary outcome
Change in Gut Microbiome Shannon Diversity Index
Time frame: Baseline and Day 30
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
19 secondary outcomes
Change in Stool Lipocalin-2 Concentration
Time frame: Baseline and Day 30
Change in Stool Calprotectin Concentration
Time frame: Baseline and Day 30
Change in Serum Monocyte Chemoattractant Protein-1 Concentration
Time frame: Baseline and Day 30
Change in Serum Interleukin-1 Beta Concentration
Time frame: Baseline and Day 30
Change in Serum Tumor Necrosis Factor-Alpha Concentration
Time frame: Baseline and Day 30
Change in Serum Interleukin-6 Concentration
Time frame: Baseline and Day 30
Change in Serum C-Reactive Protein Concentration
Time frame: Baseline and Day 30
Change in Serum Zinc Concentration
Time frame: Baseline and Day 30
Change in Serum Iodine Concentration
Time frame: Baseline and Day 30
Change in Serum Magnesium Concentration
Time frame: Baseline and Day 30
Change in Serum Folate Concentration
Time frame: Baseline and Day 30
Change in Serum Vitamin D3 Concentration
Time frame: Baseline and Day 30
Change in Serum Vitamin B12 Concentration
Time frame: Baseline and Day 30
Gut Microbiome Beta Diversity Assessed by Bray-Curtis Dissimilarity
Time frame: Baseline and Day 30
Change in EQ-5D Index Score in ADRD Participants
Time frame: Baseline and Day 30
Change in Cohen-Mansfield Agitation Inventory Total Score
Time frame: Baseline and Day 30
Change in Perceived Stress Scale Total Score in Caregivers
Time frame: Baseline and Day 30
Change in State-Trait Anxiety Inventory State Anxiety Score
Time frame: Baseline and Day 30
Change in State-Trait Anxiety Inventory Trait Anxiety Score
Time frame: Baseline and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 384602Ullrich V. Cytochrome P450 and biological hydroxylation reactions. Top Curr Chem. 1979;83:67-104. doi: 10.1007/BFb0019663. No abstract available.
- Results publication: PubMed 36565729Ekinci GN, Sanlier N. The relationship between nutrition and depression in the life process: A mini-review. Exp Gerontol. 2023 Feb;172:112072. doi: 10.1016/j.exger.2022.112072. Epub 2022 Dec 21.
- Results publication: PubMed 39064731Covello C, Becherucci G, Di Vincenzo F, Del Gaudio A, Pizzoferrato M, Cammarota G, Gasbarrini A, Scaldaferri F, Mentella MC. Parenteral Nutrition, Inflammatory Bowel Disease, and Gut Barrier: An Intricate Plot. Nutrients. 2024 Jul 17;16(14):2288. doi: 10.3390/nu16142288.
- Results publication: PubMed 38084827Roth-Walter F, Berni Canani R, O'Mahony L, Peroni D, Sokolowska M, Vassilopoulou E, Venter C. Nutrition in chronic inflammatory conditions: Bypassing the mucosal block for micronutrients. Allergy. 2024 Feb;79(2):353-383. doi: 10.1111/all.15972. Epub 2023 Dec 12.
- Results publication: PubMed 36479795Yassine HN, Self W, Kerman BE, Santoni G, Navalpur Shanmugam N, Abdullah L, Golden LR, Fonteh AN, Harrington MG, Graff J, Gibson GE, Kalaria R, Luchsinger JA, Feldman HH, Swerdlow RH, Johnson LA, Albensi BC, Zlokovic BV, Tanzi R, Cunnane S, Samieri C, Scarmeas N, Bowman GL. Nutritional metabolism and cerebral bioenergetics in Alzheimer's disease and related dementias. Alzheimers Dement. 2023 Mar;19(3):1041-1066. doi: 10.1002/alz.12845. Epub 2022 Dec 8.
- Results publication: PubMed 36038530Puga F, Wang D, Rafford M, Poe A, Pickering CEZ. The relationship between daily stressors, social support, depression and anxiety among dementia family caregivers: a micro-longitudinal study. Aging Ment Health. 2023 Jul-Aug;27(7):1291-1299. doi: 10.1080/13607863.2022.2116392. Epub 2022 Aug 29.
- Results publication: PubMed 37414157Culberson JW, Kopel J, Sehar U, Reddy PH. Urgent needs of caregiving in ageing populations with Alzheimer's disease and other chronic conditions: Support our loved ones. Ageing Res Rev. 2023 Sep;90:102001. doi: 10.1016/j.arr.2023.102001. Epub 2023 Jul 5.
- Results publication: PubMed 38590188Chen Y, Gao X, Sun F. Perceived Threat of Alzheimer's Disease and Related Dementias Among Chinese Family Caregivers of Older Adults with Cognitive Impairment. J Gerontol Soc Work. 2024 Oct;67(7):976-994. doi: 10.1080/01634372.2024.2339984. Epub 2024 Apr 8.
- Results publication: PubMed 37310738Kivimaki M, Livingston G, Singh-Manoux A, Mars N, Lindbohm JV, Pentti J, Nyberg ST, Pirinen M, Anderson EL, Hingorani AD, Sipila PN. Estimating Dementia Risk Using Multifactorial Prediction Models. JAMA Netw Open. 2023 Jun 1;6(6):e2318132. doi: 10.1001/jamanetworkopen.2023.18132.
- Results publication: PubMed 29051531Vogt NM, Kerby RL, Dill-McFarland KA, Harding SJ, Merluzzi AP, Johnson SC, Carlsson CM, Asthana S, Zetterberg H, Blennow K, Bendlin BB, Rey FE. Gut microbiome alterations in Alzheimer's disease. Sci Rep. 2017 Oct 19;7(1):13537. doi: 10.1038/s41598-017-13601-y.
- Results publication: PubMed 37642170Zhao L, Guan L, Sun J, Li X. Serum levels of folate, vitamin B6, and vitamin B12 are associated with cognitive impairments in depression patients. Acta Neuropsychiatr. 2024 Feb;36(1):44-50. doi: 10.1017/neu.2023.41. Epub 2023 Aug 29.
- Results publication: PubMed 31477562Nagpal R, Neth BJ, Wang S, Craft S, Yadav H. Modified Mediterranean-ketogenic diet modulates gut microbiome and short-chain fatty acids in association with Alzheimer's disease markers in subjects with mild cognitive impairment. EBioMedicine. 2019 Sep;47:529-542. doi: 10.1016/j.ebiom.2019.08.032. Epub 2019 Aug 30.
- Individual participant dataSharing planned: 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)
Related trials for Alzheimer Disease Related Dementia
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruiting
Music Listening for Chronic Pain in Adults With Early-Stage Dementia
Chronic Pain, Alzheimer Disease
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Fermented Milk (PFM) Drink in people with Alzheimer Disease Related Dementia, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalini Jain, PhD (813-9746281, jains10@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiome Shannon Diversity Index (time frame: Baseline and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07800195, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.