[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654511":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":92,"studyPopulation":83,"armGroups":93,"interventions":105,"overallOfficials":83,"centralContacts":115,"locations":125,"responsibleParty":148,"collaborators":83,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":83,"enrollmentInfo":160,"targetDuration":83,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":177,"whyStopped":83,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":71},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nUnit of Measure:\n\nShannon diversity index","Baseline and Day 30",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68],{"measure":15,"description":16,"timeFrame":12},"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.\n\nUnit: ng\u002Fg stool",{"measure":18,"description":19,"timeFrame":12},"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.\n\nUnit: µg\u002Fg stool",{"measure":21,"description":22,"timeFrame":12},"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.\n\nUnit: pg\u002FmL",{"measure":24,"description":25,"timeFrame":12},"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.\n\nUnit: pg\u002FmL",{"measure":27,"description":28,"timeFrame":12},"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.\n\nUnit: pg\u002FmL",{"measure":30,"description":31,"timeFrame":12},"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.\n\nUnit: pg\u002FmL",{"measure":33,"description":34,"timeFrame":12},"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.\n\nUnit: µg\u002FmL",{"measure":36,"description":37,"timeFrame":12},"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.\n\nUnit: µg\u002FdL",{"measure":39,"description":40,"timeFrame":12},"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.\n\nUnit: µg\u002FdL",{"measure":42,"description":43,"timeFrame":12},"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.\n\nUnit: mg\u002FdL",{"measure":45,"description":46,"timeFrame":12},"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.\n\nUnit: ng\u002FmL",{"measure":48,"description":49,"timeFrame":12},"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.\n\nUnit: ng\u002FmL",{"measure":51,"description":52,"timeFrame":12},"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.\n\nUnit: pg\u002FmL",{"measure":54,"description":55,"timeFrame":12},"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.\n\nUnit of Measure:\n\nBray-Curtis dissimilarity",{"measure":57,"description":58,"timeFrame":12},"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.\n\nUnit:\n\nEQ-5D index score",{"measure":60,"description":61,"timeFrame":12},"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.\n\nUnit:\n\nCMAI total score",{"measure":63,"description":64,"timeFrame":12},"Change in Perceived Stress Scale Total Score in Caregivers","Description:\n\nChange 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.\n\nUnit:\n\nPSS total score",{"measure":66,"description":67,"timeFrame":12},"Change in State-Trait Anxiety Inventory State Anxiety Score","Description:\n\nChange 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.\n\nUnit:\n\nSTAI State Anxiety score",{"measure":69,"description":70,"timeFrame":12},"Change in State-Trait Anxiety Inventory Trait Anxiety Score","Description:\n\nChange 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.\n\nUnit:\n\nSTAI Trait Anxiety score",[72,75],{"measure":73,"description":74,"timeFrame":12},"Change in SF-36 Physical Component Summary Score","Change in the Short Form-36 (SF-36) Physical Component Summary (PCS) score from baseline to Day 30 in caregivers. A single PCS summary score will be calculated at each time point, and the outcome will be the Day 30 PCS score minus the baseline PCS score. The SF-36 Mental Component Summary score is reported as a separate outcome measure.\n\nUnit: PCS score",{"measure":76,"description":77,"timeFrame":12},"Change in SF-36 Mental Component Summary Score","Change in the Short Form-36 (SF-36) Mental Component Summary (MCS) score from baseline to Day 30 in caregivers. A single MCS summary score will be calculated at each time point, and the outcome will be the Day 30 MCS score minus the baseline MCS score. The SF-36 Physical Component Summary score is reported as a separate outcome measure.\n\nUnit:\n\nMCS score",{"allocation":79,"interventionModel":80,"interventionModelDescription":81,"primaryPurpose":82,"observationalModel":83,"timePerspective":83,"maskingInfo":84},"RANDOMIZED","PARALLEL","ADRD and caregivers","TREATMENT",null,{"masking":85,"maskingDescription":86,"whoMasked":87},"QUADRUPLE","double-blind, randomized, placebo-controlled clinical trial.",[88,89,90,91],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nParticipants 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.\n\nBiological 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.\n\nClinical 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.\n\nThe 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.",[94,101],{"label":95,"type":96,"description":97,"interventionNames":98},"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.\n\nParticipants 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.",[99,100],"Dietary Supplement: Probiotic Fermented Milk (PFM) Drink","Dietary Supplement: Placebo",{"label":102,"type":103,"description":81,"interventionNames":104},"Placebo milk","PLACEBO_COMPARATOR",[99,100],[106,111],{"type":107,"name":108,"description":109,"armGroupLabels":110,"otherNames":83},"DIETARY_SUPPLEMENT","Probiotic Fermented Milk (PFM) Drink","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.",[102,95],{"type":107,"name":112,"description":113,"armGroupLabels":114,"otherNames":83},"Placebo","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.",[102,95],[116,121],{"name":117,"role":118,"phone":119,"phoneExt":83,"email":120},"Shalini Jain, PhD","CONTACT","813-9746281","jains10@usf.edu",{"name":122,"role":118,"phone":123,"phoneExt":83,"email":124},"Hariom Yadav, PhD","8139748222","hyadav@usf.edu",[126],{"facility":127,"status":83,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":139},"Center for Microbiome Research, Microbiomes Institute, University of South Florida, Tampa, FL, 33620","Tampa","Florida","33612","United States","US",{"type":134,"coordinates":135},"Point",[136,137],-82.45843,27.94752,{"lat":137,"lon":136},[140,141,145,147],{"name":117,"role":118,"phone":119,"phoneExt":83,"email":120},{"name":142,"role":118,"phone":143,"phoneExt":83,"email":144},"Dhananjay Yadav, PhD","8134521781","dhananjay11@usf.edu",{"name":122,"role":146,"phone":83,"phoneExt":83,"email":83},"PRINCIPAL_INVESTIGATOR",{"name":117,"role":146,"phone":83,"phoneExt":83,"email":83},{"type":149,"investigatorFullName":83,"investigatorTitle":83,"investigatorAffiliation":83,"oldNameTitle":83,"oldOrganization":83},"SPONSOR","100654511","probiotic-milk-drink-for-gut-and-brain-health-in-older-adults-and-caregivers-100654511",false,"NCT07800195","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","PFM","Inclusion Criteria:• Diagnosed with ADRD and accompanied with their caregiver\n\n* Age ≥ 18 years old\n* Willing to consume PFM and\u002For willing to consume placebo drink, follow instructions of study team and sign consent form\n\nExclusion Criteria:\n\n* Lactose intolerance or another intolerance that prevents the safe consumption of dairy products\n* Allergy to any ingredients in the PFM formulations, including almonds\u002Fnuts, lactose\u002Fdairy, dextrose, artificial sweeteners, or dyes used in flavoring\n* Known allergy or hypersensitivity to peanuts or soy, as indicated on the pectin product label.\n* Known allergy, intolerance, or hypersensitivity to Ensure® or any of its components.\n* Cancer patients receiving chemotherapy, due to potential increased risk of infection from GI tract damage\n* 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.\n* Major surgery(ies) of the gut or brain within the past five years\n* 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\n* Small intestinal bacterial overgrowth\n* History of anticipatory nausea, vomiting, constipation, or diarrhea\n* Antibiotic or probiotic or heavy yogurt (3 servings per day) use within the past 30 days\n\n  o Probiotic use is defined as consumption of ≥108 CFU\u002Fday, in the form of tablets, capsules, lozenges, powders, or dairy products in which probiotics are a major ingredient\n* Critical or terminal illnesses including diabetes\n* 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.\n* Significant mental health conditions","ALL","18 Years",{"count":161,"type":162},40,"ESTIMATED","INTERVENTIONAL",[165],"NA","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.\n\nParticipants 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.\n\nEach 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.",[168],"Alzheimer Disease Related Dementia",[170,171,172,173,174,175,176],"caregivers","Probiotic fermented milk","Gut microbiome","Gut-brain axis","Microbiome diversity","Nutrient absorption","Randomized controlled trial","NOT_YET_RECRUITING","2026-08-28",{"date":180,"type":181},"2026-09-02","ACTUAL",{"date":183,"type":162},"2026-09-01",{"date":185,"type":162},"2026-10-20",{"name":5,"class":6},1]