[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610350":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":44,"locations":54,"responsibleParty":79,"collaborators":49,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":49,"enrollmentInfo":91,"targetDuration":49,"studyType":94,"phases":95,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":57,"whyStopped":49,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Colesevelam first","ACTIVE_COMPARATOR","Participants randomized to this arm will receive colesevelam, taking 3 tablets twice daily for 12 weeks, followed by a 2-week washout period, and then 12 weeks of matching placebo tablets taken on the same schedule. Both the study drug and the placebo will be provided in identical-appearing bottles to maintain blinding.",[13,14],"Drug: Colesevelam","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo first","PLACEBO_COMPARATOR","Participants randomized to this arm will receive placebo tablets, taking 3 tablets twice daily for 12 weeks, followed by a 2-week washout period, and then 12 weeks of colesevelam (3 tablets twice daily). Both the study drug and the placebo will be provided in identical-appearing bottles to maintain blinding.",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Colesevelam","Colesevelam in 625-mg tablets. Participants will take 3 tablets orally, twice daily (total daily dose 3.75 g) for 12 weeks.",[9,16],[27],"Welchol",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Matching inert oral tablets designed to mimic colesevelam 625 mg tablets in size, shape, and color, but containing no active pharmaceutical ingredient. Participants will take 3 orally, twice per day for 12 weeks.",[9,16],[33],"Inert oral tablets",[35,39,41],{"name":36,"affiliation":37,"role":38},"Ashley E Mason, PhD","University of California San Francisco, Osher Center for Integrative Health","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":38},"Leena Pandya, ND",{"name":42,"affiliation":37,"role":43},"Sarah Fisher, MS","STUDY_DIRECTOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Ashley Mason, PhD","CONTACT","415-514-6820",null,"enginestudy@ucsf.edu",{"name":40,"role":47,"phone":52,"phoneExt":49,"email":53},"415-502-1619","leena.pandya@ucsf.edu",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"UCSF Osher Center for Integrative Health","RECRUITING","San Francisco","California","94115","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-122.41942,37.77493,{"lat":67,"lon":66},[70,71,72,74,77],{"name":40,"role":47,"phone":49,"phoneExt":49,"email":50},{"name":36,"role":38,"phone":49,"phoneExt":49,"email":49},{"name":73,"role":38,"phone":49,"phoneExt":49,"email":49},"Leena S Pandya, ND",{"name":75,"role":76,"phone":49,"phoneExt":49,"email":49},"Rick M Hecht, MD","SUB_INVESTIGATOR",{"name":78,"role":76,"phone":49,"phoneExt":49,"email":49},"Wendy Hartogensis, PhD, MPH",{"type":80,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100610350","phase-1-examining-a-novel-gastrointestinal-intervention-to-negate-environmental-toxicants-engine-100610350",false,"NCT07226440","Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)","Assessing the Impact of a Bile Acid Sequestrant on Serum PFAS Levels in Highly Exposed Individuals","ENGINE","Inclusion Criteria:\n\n* Male firefighter, active or retired\n* California resident\n* Age 18 or older\n* English-speaking\n* Access to a reliable internet connection\n* Willing to attend 3 in-person study visits in the San Francisco Bay Area over about 6.5 months\n* Willing to receive weekly text message reminders to complete online surveys\n* Willing to complete a mail-based, at-home finger-prick blood test\n* Willing to take 3 tablets (each tablet about the size of a multivitamin) orally twice daily for a total of 6 months\n* Evaluated by study team to have an elevated risk of PFAS exposure (e.g., duration of firefighting service, prior NASEM-7 result greater than or equal to 10 ng\u002FmL)\n\nExclusion Criteria:\n\n* Gastroparesis or other severe gastrointestinal motility disorders\n* Bowel obstruction\n* History of major gastrointestinal tract surgery\n* Dysphagia or difficulty swallowing (due to tablet size)\n* History of hypertriglyceridemia (triglycerides exceeding 500 mg\u002FdL)\n* History of hypertriglyceridemia-induced pancreatitis\n* Type 1 or 2 diabetes\n* History of fat-soluble vitamin deficiencies, i.e., vitamins A, D, E, or K\n* Phenylketonuria\n* History of known bleeding\u002Fclotting disorders\n* Medications or treatments that may impact the excretion of PFAS, such as activated charcoal, other bile acid sequestrants, chelation therapies, etc.\n* Unalterable plans to donate blood or plasma during the study participation period","MALE","18 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96,97],"PHASE1","PHASE2","This randomized, placebo-controlled crossover trial will test the feasibility and acceptability of using colesevelam in male firefighters with high per- and polyfluoroalkyl substances (PFAS) exposure. This trial will also explore whether colesevelam lowers blood PFAS levels and urine environmental toxicant and mold mycotoxin levels.",[100,101,102],"Toxicant Exposure","Firefighter","Occupational Exposure to Chemicals",[104,105,106,107,108,23],"Per- and polyfluoroalkyl substances","PFAS","Firefighters","Occupational exposure","Bile acid sequestrants","2026-04-22",{"date":111,"type":112},"2026-04-24","ACTUAL",{"date":114,"type":112},"2026-03-01",{"date":116,"type":93},"2028-12",{"name":5,"class":6},1]