[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624754":3},{"organization":4,"outcomesModule":7,"designInfo":89,"detailedDescription":99,"studyPopulation":11,"armGroups":100,"interventions":118,"overallOfficials":130,"centralContacts":138,"locations":144,"responsibleParty":162,"collaborators":164,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":11,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":179,"minAge":180,"maxAge":11,"enrollmentInfo":181,"targetDuration":11,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":147,"whyStopped":11,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":25},[9,13,15,17,20,23],{"measure":10,"description":11,"timeFrame":12},"Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study",null,"up to 36 weeks",{"measure":14,"description":11,"timeFrame":12},"Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study",{"measure":16,"description":11,"timeFrame":12},"Feasibility: Number of weeks or months needed to meet study group numbers",{"measure":18,"description":11,"timeFrame":19},"Feasibility: Proportion of individuals expressing interest in study who are Eligible","baseline",{"measure":21,"description":11,"timeFrame":22},"Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS","week 24",{"measure":24,"description":11,"timeFrame":12},"Feasibility: Proportion of Participants Who Complete Intervention",[26,29,32,34,36,38,40,42,44,46,48,51,54,57,60,64,68,71,74,77,80,83,86],{"measure":27,"description":11,"timeFrame":28},"Hemoglobin A1C","baseline, week 12, week 24, and week 36",{"measure":30,"description":11,"timeFrame":31},"Fasting Glucose","baseline, week 12, week 24, week 36",{"measure":33,"description":11,"timeFrame":31},"Fasting Insulin",{"measure":35,"description":11,"timeFrame":31},"C-reactive protein",{"measure":37,"description":11,"timeFrame":31},"Blood lipid profile",{"measure":39,"description":11,"timeFrame":31},"Systolic Blood Pressure",{"measure":41,"description":11,"timeFrame":31},"Diastolic Blood Pressure",{"measure":43,"description":11,"timeFrame":31},"Body Weight",{"measure":45,"description":11,"timeFrame":31},"Body Fat Percentage",{"measure":47,"description":11,"timeFrame":31},"Insulin Resistance indexed by the homeostatic model assessment-insulin resistance (HOMA-IR) method",{"measure":49,"description":50,"timeFrame":31},"Change in Quality of Sleep","General sleep quality will be rated using a 10 item questionnaire, which uses a 6-point Likert scale. Scores range from 10-60, with higher scores indicating better sleep quality.",{"measure":52,"description":53,"timeFrame":31},"Metabolites","Measured from serum, plasma, stool",{"measure":55,"description":56,"timeFrame":31},"Gut Microbiome Composition","Change in gut microbiome composition will be assessed using 16srRNA seq and metagenomic analysis of stool samples.",{"measure":58,"description":59,"timeFrame":31},"Plasma Biomarkers of Alzheimer's Disease Related Dementias (ADRD)","Change in plasma biomarkers of ADRD, including pTau217, neurofilament light chain (NfL), and Glial Fibrillary Acidic Protein (GFAP). Emerging plasma biomarkers may also be assessed.",{"measure":61,"description":62,"timeFrame":63},"Change in Montreal Cognitive Assessment (MoCA) score","The MoCA is a cognitive screening test used for detecting cognitive impairment. MoCA scores range between 0 and 30. Lower scores are indicative of impairment.","screening, week 24, week 36",{"measure":65,"description":66,"timeFrame":67},"Change in Repeatable Battery for the Assessment of Neuropsychological Status: Performance","The Repeatable Battery for the Assessment of Neuropsychological Status consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial\u002Fconstructional, language, attention, delayed memory). Raw scores on each domain are scaled to account for a person's age. Scaled scores are converted to percentiles which are used to determine a range of performance (impaired, borderline impaired, expected score, high average, superior).","baseline, week 24, week 36",{"measure":69,"description":70,"timeFrame":67},"Change in Repeatable Battery for the Assessment of Neuropsychological Status: Cognitive Status","The Repeatable Battery for the Assessment of Neuropsychological Status consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial\u002Fconstructional, language, attention, delayed memory). Raw scores on each domain are scaled to account for a person's age. Scaled scores are converted to percentiles which are used to determine overall cognitive status (impaired\u002Fnot impaired).",{"measure":72,"description":73,"timeFrame":67},"Change in the results of Trail Making Test (TMT)","The TMT is a neuropsychological test of visual attention and task switching. It consists of two parts, A and B. Participant is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.\n\nResults for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.",{"measure":75,"description":76,"timeFrame":31},"Total score on the Bristol Activities of Daily Living Scale","This is a tool used to measure functional ability (ability to independently carry out activities of daily living), and was developed for use with people with dementia. The minimum score is \"0\". The maximum score is \"60\". A lower score (better) indicates that a person is independent in their activities of daily living, and a higher score (worse) indicates that the individual is dependent on others.",{"measure":78,"description":79,"timeFrame":31},"Intestinal Permeability","Investigators may measure proteins or other markers related to intestinal permeability (in blood).",{"measure":81,"description":82,"timeFrame":31},"Change in Epworth Sleepiness Scale (ESS)","ESS is an 8 item questionnaire, using a 4-point Likert scale. Scores range from 0-24, with higher scores indicating greater levels of sleepiness throughout the day.",{"measure":84,"description":85,"timeFrame":31},"Change in Insomnia Severity Index (ISI)","ISI is an 7 item questionnaire, using a 5-point Likert scale. Scores range from 35-24, with higher scores indicating greater levels of insomnia.",{"measure":87,"description":88,"timeFrame":31},"Change in Pittsburgh Sleep Quality Index (PSQI)","PSQI scoring involves summing scores from 7 components, each ranging from 0 (no difficulty) to 3 (severe difficulty), to get a global score from 0 to 21, with higher scores indicating worse sleep quality. A global score over 5 suggests significant sleep difficulties.",{"allocation":90,"interventionModel":91,"interventionModelDescription":92,"primaryPurpose":93,"observationalModel":11,"timePerspective":11,"maskingInfo":94},"RANDOMIZED","PARALLEL","Safety and feasibility study, randomized, double blinded, placebo-controlled","TREATMENT",{"masking":95,"maskingDescription":11,"whoMasked":96},"DOUBLE",[97,98],"PARTICIPANT","OUTCOMES_ASSESSOR","40 participants will be enrolled. 20 with dementia or mild cognitive impairment (MCI) due to Alzheimer's disease (biomarker confirmed amyloid positivity), and 20 unimpaired cognition, enriched for elevated amyloid (approximately 75-80% amyloid positive). Dementia\u002Fmild cognitive impairment will be determined according to 2024 NIA-AA criteria.\n\nPrimary Objective\n\n* To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral probiotic supplementation (PS) intervention in humans with or at risk for dementia due to AD.\n\nExploratory Objectives\n\n* To demonstrate the effects of PS on the composition and function of the gut microbiota in humans with or at risk for dementia due to AD.\n* To collect preliminary data in order to estimate sample size and other critical parameters for a larger study.\n* To examine potential mechanisms by which the gut impacts brain, including leading candidate mechanisms such as intestinal permeability and change to bile acid milieu.",[101,107,112,115],{"label":102,"type":103,"description":104,"interventionNames":105},"Cognitively Impaired due to AD: Probiotic","EXPERIMENTAL","Diagnosis of mild cognitive impairment (MCI) or dementia",[106],"Drug: Probiotic",{"label":108,"type":109,"description":104,"interventionNames":110},"Cognitively Impaired due to AD: Placebo","PLACEBO_COMPARATOR",[111],"Other: Placebo",{"label":113,"type":103,"description":11,"interventionNames":114},"Cognitively Unimpaired Amyloid Positive: Probiotic",[106],{"label":116,"type":109,"description":11,"interventionNames":117},"Cognitively Unimpaired Amyloid Positive: Placebo",[111],[119,126],{"type":120,"name":121,"description":122,"armGroupLabels":123,"otherNames":124},"DRUG","Probiotic","A single dose of oral PS will be administered once daily for 6 months",[102,113],[125],"Encapsulated probiotic preparation",{"type":6,"name":127,"description":128,"armGroupLabels":129,"otherNames":11},"Placebo","A placebo will be given once daily for 6 months.",[108,116],[131,135],{"name":132,"affiliation":133,"role":134},"Barbara Bendlin, PhD","UW School of Medicine and Public Health","PRINCIPAL_INVESTIGATOR",{"name":136,"affiliation":137,"role":134},"Federico Rey, PhD","Department of Bacteriology",[139],{"name":140,"role":141,"phone":142,"phoneExt":11,"email":143},"Alfred Braceros, BA","CONTACT","608-263-9485","braceros@medicine.wisc.edu",[145],{"facility":146,"status":147,"city":148,"state":149,"zip":150,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":158,"contacts":159},"University of Wisconsin Hospitals and Clinics","RECRUITING","Madison","Wisconsin","53792","United States","US",{"type":154,"coordinates":155},"Point",[156,157],-89.40123,43.07305,{"lat":157,"lon":156},[160,161],{"name":132,"role":134,"phone":11,"phoneExt":11,"email":11},{"name":136,"role":134,"phone":11,"phoneExt":11,"email":11},{"type":163,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[165,168],{"name":166,"class":167},"International Flavors & Fragrances Inc.","UNKNOWN",{"name":169,"class":170},"National Institute on Aging (NIA)","NIH","100624754","phase-2-the-gut---pro-study-100624754",false,"NCT07413744","The Gut - PRO Study","Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease","Inclusion Criteria:\n\n* MCI\u002FAD or cognitively unimpaired, referred from a Wisconsin clinic that is part of the Wisconsin Alzheimer's Institute's (WAI) network, or recruited from the community. May have participated in:\n\n  * Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030)\n  * ADCP (26695, MCW IRB)\n  * Synapse study (2018-1283)\n  * ADRC Recruitment Registry (2016-0735)\n* At least 60 years of age or older\n* Good general health (other than cognitive impairment\u002Fdementia) with no conditions\u002Fmedications affecting the gut microbiome (see exclusion criteria below)\n* Willing and able to comply with all study procedures for the duration of the study\n* Able to provide signed and dated informed consent form\n* Participant is not pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)\n* Able to take oral medications\n* An informant to answer questionnaires about the participant\n\nAdditional inclusion criteria for unimpaired participants:\n\n* Has MOCA score that falls within the range defined for cognitively healthy individuals\n\nAdditional inclusion criteria for participants with MCI\u002FAD\n\n* Abnormal cognitive function documented by neuropsychological testing\n* ADRC (2015-0030) Consensus Diagnosis Conference indicates dementia or MCI due to AD (for ADRC, ADCP, and Synapse participants only)\n* Meets NIA-AA criteria for MCI or AD.\n\nExclusion Criteria:\n\n* Active or previous (within 6 months) participation in an Alzheimer's clinical intervention\u002Ftrial (can be included if previously enrolled in placebo or control group)\n* Standard clinical care for dementia and medications used to treat MCI and Alzheimer's disease are acceptable, including monoclonal antibody therapy\n* Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits other than Alzheimer's or Mild Cognitive Impairment\n* Alcohol\u002Fsubstance: history of alcohol\u002Fsubstance dependence in the past year.\n* Significant medical illness: any significant systemic illness or unstable medical condition occurring during ADRC participation that could affect cognition (other than MCI\u002FAD). Examples include malignant cancer, chemotherapy, HIV, untreated thyroid disease, heart failure, or renal insufficiency\n* Current diagnosis with diabetes\n* Illiterate, blind, or non-English speaking\n* Known periodic antibiotic use (i.e., prior to dental appointments)\n* Oral PS-specific exclusion criteria:\n\n  * Inability (e.g., dysphagia) or unwilling to swallow capsules\n  * Active gastrointestinal infection at time of enrollment\n  * Known or suspected toxic megacolon and\u002For known small bowel ileus\n  * History of total colectomy or bariatric surgery\n  * Concurrent intensive induction chemotherapy, radiation therapy, or biological treatment for active malignancy\n  * Unable or unwilling to comply with protocol requirements\n  * Expected life expectancy less than 6 months\n  * Previous use of probiotic supplementation (PS) or microbiome-based products within 2 months, large doses of commercial probiotics consumed (greater than or equal to 10\\^8 cfu or organisms per day). Includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component (ordinary dietary components such as fermented beverages\u002Fmilks, yogurts, foods do not apply). Enrollment after 2 months without probiotic use can be considered for eligibility\n  * Patients with severe anaphylactic or anaphylactoid food allergy\n  * Solid organ transplant recipients less than or equal to 90 days post-transplant or on active treatment for rejection\n  * A condition that would jeopardize the safety or rights of the participant, would make it unlikely for the participant to complete the study, or would confound the results of the study\n* Exclusionary factors affecting the microbiome:\n\n  * Previous use of systemic antibiotics (intravenous, intramuscular, or oral) within 3 months (depends on the duration of antibiotic use, i.e., less than 3 months is considered exclusion, however, enrollment after 3 months without antibiotic use can be considered for eligibility)\n  * Immune stimulating and\u002For suppressing medications\n  * Immunosuppressed as evaluated by complete blood count (CBC) with differential, which includes white blood cell count, total neutrophil count, and total lymphocyte count\n  * Unstable dietary history during the previous month, which is defined as major changes in diet by eliminating or significantly increasing a major food group\n  * Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years\n  * Major bowel resection at any time\n  * Active uncontrolled gastrointestinal disorders or disease including inflammatory bowel disease, ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis; irritable bowel syndrome (moderate-severe); persistent, infectious gastroenteritis, colitis, or gastritis; persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated), or chronic constipation",true,"ALL","60 Years",{"count":182,"type":183},40,"ESTIMATED","INTERVENTIONAL",[186],"PHASE1","The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.",[189],"Alzheimer Disease",[191],"probiotics","2026-09-28",{"date":194,"type":195},"2026-09-29","ACTUAL",{"date":197,"type":183},"2026-10",{"date":199,"type":183},"2029-09",{"name":5,"class":6},1]