[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657320":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":29,"armGroups":38,"interventions":46,"overallOfficials":61,"centralContacts":65,"locations":73,"responsibleParty":89,"collaborators":29,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":29,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":29,"enrollmentInfo":101,"targetDuration":29,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":116,"whyStopped":29,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Emory University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Serum NASEM ΣPFAS concentration","The summed serum PFAS concentration (in ng\u002FmL) according to a definition recommended by the National Academies of Sciences, Engineering, and Medicine (NASEM) will be measured.","Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Shannon diversity index","The Shannon Diversity Index will be used to assess the diversity of microorganisms in the gut microbiome. The measure considers both the number of different types of microorganisms present and their relative abundance. Higher values indicate greater microbial diversity.",{"measure":18,"description":19,"timeFrame":12},"Species richness","Species richness will be used to assess the number of different microbial species detected in the gut microbiome. Higher values indicate a greater variety of microbial species.",{"measure":21,"description":22,"timeFrame":12},"Functional pathway abundance","Functional pathway abundance will be used to assess the relative abundance of microbial genes associated with specific biological functions or metabolic pathways in the gut microbiome.",{"measure":24,"description":25,"timeFrame":12},"Strain richness","The number of distinct microbial strains detected in the gut microbiome. Higher values indicate a greater variety of microbial strains.",{"measure":27,"description":28,"timeFrame":12},"Taxa abundance","Taxa abundance will be used to assess changes in the relative abundance of specific groups of microorganisms in the gut microbiome.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"NA","SINGLE_GROUP","Stepped wedge randomized control trial","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":29},"NONE","The objective of this study is to assess whether cholestyramine, a bile acid sequestrant approved for the treatment of high cholesterol, can reduce the body burden of per- and polyfluoroalkyl substances (PFAS). PFAS are persistent chemicals that can accumulate in the body and have been associated with adverse health effects.\n\nThe study will enroll 300 adults from Rome and Calhoun, Georgia. Participants will complete four study visits which will include providing blood, urine, and fecal samples, as well as answering questionnaires. As part of the study, participants will be prescribed cholestyramine therapy for either one, two, three, or four months (up to 120 days) using a stepped-wedge trial study design. The study duration is 4 months for each participant.\n\nBiospecimens will be stored for future research use. Written informed consent will be obtained from all participants before any study procedures are performed.",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"Cholestyramine therapy Group","EXPERIMENTAL","Participants will receive cholestyramine therapy for one, two, three, or four months (up to 120 days in total).The dose will be escalated from 4 g\u002Fday during Week 1 to 8 g\u002Fday during Week 2 and 12 g\u002Fday thereafter for their remaining weeks while on the intervention (between 2-14 weeks depending on the study arm).\n\nParticipants will additionally be given a bottle of Centrum-brand multivitamins at the first visit, with the option to take these vitamins daily as indicated on the multivitamin packing, while they are participating in the study (up to 120 days).",[44,45],"Drug: Cholestyramine","Drug: Centrum",[47,54],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Cholestyramine","Participants will be randomized to be prescribed cholestyramine therapy for one, two, three, or four months (up to 120 days in total).\n\nParticipants will be prescribed cholestyramine at a dose of 4 grams daily (one dose) for the first week, 8 grams daily (two doses) for the second week, and 12 grams daily (three doses) for their remaining weeks while on the intervention (between 2-14 weeks depending on the study arm).",[40],[53],"Cholestyramine resin",{"type":48,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Centrum","A bottle of Centrum-brand multivitamins will be provided at the first visit, with the option to take these vitamins daily as indicated on the multivitamin packing, while they are participating in the study (up to 120 days). The multivitamins are recommended as cholestyramine can lead to low levels of vitamins after long-term use.",[40],[59,60],"Multivitamin","Centrum Adult Multivitamin",[62],{"name":63,"affiliation":5,"role":64},"Stephanie Eick, PhD","PRINCIPAL_INVESTIGATOR",[66,70],{"name":63,"role":67,"phone":68,"phoneExt":29,"email":69},"CONTACT","404-829-4813","ngapfas@emory.edu",{"name":71,"role":67,"phone":29,"phoneExt":29,"email":72},"Alina Merceron, MPH","alina.merceron@emory.edu",[74],{"facility":5,"status":29,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Atlanta","Georgia","30322","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-84.38798,33.749,{"lat":84,"lon":83},[87],{"name":63,"role":67,"phone":29,"phoneExt":29,"email":88},"stephanie.marie.eick@emory.edu",{"type":64,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Stephanie Eick","Assistant Professor","100657320","phase-2-pfas-clinical-trial-100657320",false,"NCT07836023","PFAS Clinical Trial","Unbinding Forever Chemicals: an Intervention Trial for Reducing PFAS Body Burden and Assessing the Role of the Microbiome","Inclusion Criteria:\n\n* Age 18 years or older\n* Residence in Floyd or Gordon County, Georgia\n* Residence in the study area for at least 5 years\n* No plans to relocate from the study area within the next 6 months\n* Able to communicate in English\n* Not currently pregnant\n* Primarily drinks tap water\n\nExclusion Criteria:\n\n* Taken antibiotics in the last three months\n* Currently taking a BAS or drugs with known contraindications, bowel or stomach resections, malabsorptive conditions, documented celiac or irritable bowel disease\n* Stage 4 or higher chronic kidney disease\n* Hospitalization with acute condition in the last three months\n* History of malignant carcinoma.","ALL","18 Years",{"count":102,"type":103},300,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The purpose of this study is to evaluate whether treatment with cholestyramine for either one, two, three, or four months (up to 120 days), meaningfully influences per- and polyfluoroalkyl substances (PFAS) removal from the body.",[109],"Environmental Exposure",[111,112,113,49,114,115],"PFAS","Perfluoroalkyl Substances","Polyfluoroalkyl Substances","Bile Acid Sequestrant","Microbiome","NOT_YET_RECRUITING","2026-09-17",{"date":119,"type":120},"2026-09-23","ACTUAL",{"date":122,"type":103},"2026-11",{"date":124,"type":103},"2030-06",{"name":5,"class":6},1]