[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654400":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":17,"overallOfficials":17,"centralContacts":36,"locations":42,"responsibleParty":63,"collaborators":17,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":17,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":17,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":45,"whyStopped":17,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Gut Microbiome Shannon Diversity Index","Gut microbiome alpha diversity will be quantified from stool samples using the Shannon diversity index. At baseline, Shannon diversity will be assessed across young healthy adults, cognitively healthy older adults, participants with mild cognitive impairment (MCI), and participants with Alzheimer's disease\u002Fdementia. Young healthy adults, cognitively healthy older adults, and participants with MCI will also be assessed annually to evaluate longitudinal changes in gut microbiome diversity. Participants with Alzheimer's disease\u002Fdementia will undergo baseline assessment only.","Baseline for all participants and annually for up to 5 years for longitudinally followed participants",[14],{"measure":15,"description":16,"timeFrame":12},"Montreal Cognitive Assessment (MoCA) Score","Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). MoCA scores will be assessed at baseline across the study groups. Young healthy adults, cognitively healthy older adults, and participants with mild cognitive impairment (MCI) will also be assessed annually to evaluate longitudinal changes in cognitive function. Participants with Alzheimer's disease\u002Fdementia will undergo baseline assessment only.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","The Microbiome in Aging Gut and Brain (MiaGB) Study is a multisite observational study investigating relationships among the gut and oral microbiome, cognitive function, microbial metabolites, intestinal permeability, inflammation, and other biological characteristics associated with aging and cognitive impairment.\n\nThe study consists of two interconnected phases.\n\nPhase 1 is a baseline cross-sectional assessment. A total of 700 participants are planned, including 100 young healthy adults, 300 cognitively healthy older adults, 200 older adults with mild cognitive impairment (MCI), and 100 older adults with Alzheimer's disease or related dementia. Baseline assessments include demographic and medical history information, cognitive function, dietary information, and selected physical function assessments. Biological samples may include stool, oral swabs, saliva, blood, and urine.\n\nLaboratory analyses may include characterization of the gut and oral microbiome, metabolomics, markers of intestinal permeability and inflammation, proteomics, transcriptomics, genetic analyses, mitochondrial function, immunophenotyping, and other protocol-specified biological assessments. These data will be examined to determine whether microbial and biological patterns differ among participants with different levels of cognitive function.\n\nPhase 2 is a prospective longitudinal follow-up. Young healthy adults, cognitively healthy older adults, and participants with MCI will be reassessed approximately annually for up to 5 years. Longitudinal assessments will be used to evaluate whether changes in the microbiome and related biological measures are associated with changes in cognitive function and whether these measures may help identify individuals at increased risk of cognitive decline. Participants with Alzheimer's disease or related dementia will undergo baseline assessment only and will not participate in the 5-year longitudinal follow-up.\n\nThis is an observational study. Participants are not assigned to a drug, biological product, behavioral treatment, or other research intervention.","The study population includes young healthy adults aged 18-60 years and adults aged 60 years and older who are cognitively healthy or have mild cognitive impairment (MCI) or Alzheimer's disease\u002Frelated dementia. Participants are recruited from participating clinical sites, memory and behavioral health clinics, senior living communities, and the community. The planned enrollment is 700 participants: 100 young healthy adults, 300 cognitively healthy older adults, 200 participants with MCI, and 100 participants with Alzheimer's disease\u002Frelated dementia.",[24,27,30,33],{"label":25,"type":17,"description":26,"interventionNames":17},"Young Healthy Adults","Healthy adults aged 18-60 years with normal cognitive function. Participants undergo baseline assessments and annual follow-up for up to 5 years.",{"label":28,"type":17,"description":29,"interventionNames":17},"Cognitively Healthy Older Adults","Adults aged 60 years and older with normal cognitive function. Participants undergo baseline assessments and annual follow-up for up to 5 years.",{"label":31,"type":17,"description":32,"interventionNames":17},"Mild Cognitive Impairment (MCI)","Adults aged 60 years and older with mild cognitive impairment. Participants undergo baseline assessments and annual follow-up for up to 5 years.",{"label":34,"type":17,"description":35,"interventionNames":17},"Alzheimer's Disease\u002FDementia","Adults aged 60 years and older with Alzheimer's disease or Alzheimer's disease-related dementia. Participants undergo baseline assessment only and are not included in the 5-year longitudinal follow-up.",[37],{"name":38,"role":39,"phone":40,"phoneExt":17,"email":41},"Shalini Jain, PhD","CONTACT","813-974-8222","jains10@usf.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Neurosurgery and Brain and Spine and Faculty of USF Center for Microbiome Re-search, Microbiomes Institute","RECRUITING","Tampa","Florida","33612","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-82.45843,27.94752,{"lat":55,"lon":54},[58,62],{"name":59,"role":39,"phone":60,"phoneExt":17,"email":61},"Hariom Yadav, PhD","8139748222","hyadav@usf.edu",{"name":38,"role":39,"phone":17,"phoneExt":17,"email":41},{"type":64,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100654400","microbiome-in-aging-of-gut-and-brain-100654400",false,"NCT07799402","Microbiome in Aging of Gut and Brain","Microbiome in Aging Gut and Brain (MiaGB) Study","MiaGB","Inclusion Criteria:\n\n* Age 18-60 years for young healthy participants, or age 60 years and older for older adult participants.\n* Participants meeting one of the following cognitive categories:\n* Normal cognitive function\n* Mild cognitive impairment (MCI)\n* Alzheimer's disease or Alzheimer's disease-related dementia\n* Able to participate in the informed consent process as applicable.\n* For participants unable to provide informed consent because of cognitive impairment, consent may be obtained from a legally authorized representative (LAR) according to the approved protocol.\n\nExclusion Criteria:\n\n* History of brain or gastrointestinal surgery within the past 5 years.\n* History of cancer and\u002For cancer treatment within the past 5 years, except non-melanoma skin cancer.\n* History of systemic cancer treatment within the past 5 years.\n* Neurological disorders including epilepsy, Parkinson's disease, or amyotrophic lateral sclerosis.\n* Antibiotic use within the past 30 days.\n* Diarrhea, vomiting, and\u002For food poisoning within the past 30 days.\n* History of inflammatory bowel disease.\n* Body mass index (BMI) greater than 45 kg\u002Fm² or less than 18 kg\u002Fm².\n* Weight loss of more than 10 pounds within the past 2 weeks.",true,"ALL","18 Years",{"count":77,"type":78},700,"ESTIMATED","5 Years","OBSERVATIONAL","The Microbiome in Aging Gut and Brain (MiaGB) Study is an observational study designed to examine whether differences in the microorganisms living in the gut and mouth are associated with cognitive health and cognitive decline.\n\nThe study includes young healthy adults, cognitively healthy older adults, older adults with mild cognitive impairment (MCI), and older adults with Alzheimer's disease or related dementia. At the baseline visit, participants complete assessments of medical history, cognitive function, physical function, and diet and provide biological samples that may include stool, saliva, oral swabs, blood, and urine.\n\nResearchers will study the gut and oral microbiome and related biological factors, including metabolites and markers of intestinal permeability and inflammation, to determine whether these measures differ according to cognitive status.\n\nYoung healthy adults, cognitively healthy older adults, and participants with MCI will be followed annually for up to 5 years to evaluate changes in the microbiome and cognitive function over time. Participants with Alzheimer's disease or related dementia will participate in the baseline assessment only.\n\nNo drug, treatment, or other research intervention is assigned as part of this study.",[83,84,85],"Mild Cognitive Impairment","Alzheimer Disease (AD)","Dementia",[87,88,89,90,91,92,85,93,94,95,96,97,98],"Gut microbiome","Oral microbiome","Cognitive impairment","Cognitive decline","Mild cognitive impairment","Alzheimer's disease","Aging","Gut-brain axis","Intestinal permeability","Inflammation","Metabolomics","Microbiome diversity","2026-09-18",{"date":101,"type":102},"2026-09-21","ACTUAL",{"date":104,"type":102},"2021-09-16",{"date":106,"type":78},"2031-09",{"name":5,"class":6},1]