[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657960":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":58,"studyPopulation":50,"armGroups":59,"interventions":72,"overallOfficials":82,"centralContacts":92,"locations":102,"responsibleParty":122,"collaborators":124,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":50,"enrollmentInfo":137,"targetDuration":50,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":105,"whyStopped":50,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Cambiotics ApS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change in serum linear perfluorooctane sulfonic acid (n-PFOS)","Change in serum n-PFOS concentration (ng\u002FmL) from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.","Baseline (Day 0) to Day 84 of each intervention period",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Change in pre-specified serum PFAS levels","Change in serum concentrations (ng\u002FmL) of linear PFOA, branched PFOA, PFDoDA, PFUnDA, branched PFOS and PFNA from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.",{"measure":18,"description":19,"timeFrame":12},"Change in composite serum PFAS measure","Change in a composite PFAS measure calculated as the sum of serum PFOS, PFNA and PFDA (ng\u002FmL) from baseline to end of each 84-day intervention period, comparing the probiotic dietary supplement with placebo.",{"measure":21,"description":22,"timeFrame":12},"Change in gastrointestinal symptoms (GSRS)","Change in Gastrointestinal Symptom Rating Scale (GSRS) total score and the five subscale scores (reflux, abdominal pain, indigestion, diarrhoea, constipation).",{"measure":24,"description":25,"timeFrame":12},"Change in fatigue (MFIS)","Change in Modified Fatigue Impact Scale (MFIS) total score, a 21-item self-report measure of the impact of fatigue on physical, cognitive and psychosocial functioning.",[27,30,33,36,39,42],{"measure":28,"description":29,"timeFrame":12},"Change in fecal PFAS levels","Change in fecal concentrations of per- and polyfluoroalkyl substances measured by LC-MS\u002FMS, from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.",{"measure":31,"description":32,"timeFrame":12},"Change in fecal microbiome composition","Change in fecal microbiome composition assessed by shotgun metagenomic sequencing, from baseline to end of each 84-day intervention period, comparing the supplement with placebo.",{"measure":34,"description":35,"timeFrame":12},"Change in fecal metabolite profiles","Change in fecal metabolite panel measured by LC-MS\u002FMS, from baseline to end of each 84-day intervention period, comparing the supplement with placebo.",{"measure":37,"description":38,"timeFrame":12},"Change in additional serum PFAS biomarkers","Change in serum concentrations (ng\u002FmL) of MeFOSAA and PFHxS from baseline to end of each 84-day intervention period, comparing the supplement with placebo.",{"measure":40,"description":41,"timeFrame":12},"Change From Baseline in Serum ApoA1\u002FApoB Ratio and Concentrations of Total Bile Acids, Cystatin C, Immunoglobulins (IgA, IgG, IgM) and Cytokines (IL-6, TNF-α, IL-1β)","Change from baseline in blood biomarkers related to physiological handling of environmental compounds: ApoA1\u002FApoB ratio, total serum bile acids, cystatin C, immunoglobulins (IgA, IgG, IgM) and cytokines (IL-6, TNF-α, IL-1β), measured at Day 0 and Day 84 of each intervention period.",{"measure":43,"description":44,"timeFrame":12},"Change From Baseline in Blood Concentrations of Bisphenols, Organophosphate Flame Retardants, Phthalate Metabolites, Parabens, 1-Hydroxypyrene, Benzophenone-3, Nicotine and Cotinine","Change from baseline in blood concentrations of bisphenols, organophosphate flame retardants, phthalate metabolites, parabens, 1-hydroxypyrene, benzophenone-3, nicotine and cotinine, measured at Day 0 and Day 84 of each intervention period",{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":50,"timePerspective":50,"maskingInfo":51},"RANDOMIZED","CROSSOVER","Two-period, two-sequence crossover. Participants are randomized 1:1 to the order of study product and placebo, with each 84-day intervention period separated by a 28-day washout.","BASIC_SCIENCE",null,{"masking":52,"maskingDescription":53,"whoMasked":54},"TRIPLE","The Sponsor is also blinded to treatment allocation. The randomization list is prepared by a statistician not involved in the conduct of the study.",[55,56,57],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This randomized, placebo-controlled, double-blind, crossover pilot study will use serum PFAS measurements, questionnaires and stool sample analyses to evaluate changes in PFAS levels, gastrointestinal symptoms and fatigue with a probiotic dietary supplement compared to a placebo. Each crossover period will last 12 weeks, separated by a four-week washout period. The study will consist of eight study visits: Screening Visit, Period 1 Baseline Visit (Day 0), Day 42 Call, Period 1 Day 84 Visit, Day 98 Call, Period 2 Baseline Visit (Day 112), Day 156 Call, and Period 2 Day 196 Visit.",[60,67],{"label":61,"type":62,"description":63,"interventionNames":64},"Sequence A: Study Product then Placebo","EXPERIMENTAL","Participants consume the probiotic dietary supplement (one capsule twice daily) for 84 days, followed by a 28-day washout, then placebo (one capsule twice daily) for 84 days.",[65,66],"Dietary Supplement: Streptococcus salivarius 46-SL1","Dietary Supplement: Placebo",{"label":68,"type":69,"description":70,"interventionNames":71},"Sequence B: Placebo then Study Product","PLACEBO_COMPARATOR","Participants consume placebo (one capsule twice daily) for 84 days, followed by a 28-day washout, then the probiotic dietary supplement (one capsule twice daily) for 84 days.",[65,66],[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":50},"DIETARY_SUPPLEMENT","Streptococcus salivarius 46-SL1","One capsule (\\~400 mg live probiotic) consumed twice daily with water, in the morning with breakfast and with the evening meal, for 84 days.",[61,68],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":50},"Placebo","Matching placebo capsule containing microcrystalline cellulose, magnesium stearate and silicon dioxide, consumed twice daily with water for 84 days.",[61,68],[83,86,90],{"name":84,"affiliation":5,"role":85},"Klavs Kirk","STUDY_DIRECTOR",{"name":87,"affiliation":88,"role":89},"Stacey Boetto, DNP, FNP-C","Atlantia Food Clinical Trials","PRINCIPAL_INVESTIGATOR",{"name":91,"affiliation":5,"role":85},"Emilie Glad Bak, PhD",[93,98],{"name":94,"role":95,"phone":96,"phoneExt":50,"email":97},"Abigail O'Mahony, Operations Manager","CONTACT","+1 312 535-9440","aomahoney@atlantiatrials.com",{"name":99,"role":95,"phone":100,"phoneExt":50,"email":101},"Stacey Boetto, Princpal Investigator, DNP, FNP-C","312-535-9440","sboetto@atlantiatrials.com",[103],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Atlantia Clinical Trials","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":112,"coordinates":113},"Point",[114,115],-87.65005,41.85003,{"lat":115,"lon":114},[118,120,121],{"name":119,"role":95,"phone":96,"phoneExt":50,"email":97},"Abigail O'Mahony",{"name":50,"role":95,"phone":50,"phoneExt":50,"email":101},{"name":87,"role":89,"phone":50,"phoneExt":50,"email":50},{"type":123,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR",[125],{"name":88,"class":6},"100657960","effect-of-a-dietary-supplement-versus-placebo-on-serum-pfas-levels-in-male-firefighters-100657960",false,"NCT07846371","Effect of a Dietary Supplement Versus Placebo on Serum PFAS Levels in Male Firefighters","A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study Evaluating a Dietary Supplement Supporting Natural Elimination Processes in Male Firefighters","AFCRO202","Inclusion Criteria:\n\n* Able to give written informed consent\n* Male firefighter with previous career exposure to PFAS\n* BMI between 18.5 and 35 kg\u002Fm²\n* Serum PFOS level ≥5 ng\u002FmL at screening\n* Willing to consume the study product daily for the duration of the study\n\nExclusion Criteria:\n\n* History of drug and\u002For alcohol abuse (\\>15 standard drinks per week)\n* Food allergy, intolerance or dietary restriction that, in the opinion of the investigator, would preclude consumption of the study product\n* Blood donation within the past 3 months\n* Current smoker of \\>20 cigarettes per day, or former smoker with a history of ≥20 cigarettes per day who quit within 6 months prior to Visit 1\n* Any significant acute or chronic health condition that would prevent participation, pose a risk, or confound interpretation of results, including: diagnosed gastrointestinal disorders (irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, ulcerative colitis, coeliac disease, or other chronic diarrhoeal disorders); uncontrolled medical conditions; history of chronic kidney or liver disease; chronic inflammatory or autoimmune disease; history of gastrointestinal surgery; hospitalisation within the past 3 months\n* Current or recent (past 12 weeks) use of medications affecting bile acid metabolism (e.g. bile acid sequestrants, fibrates) or antibiotics\n* Current or recent (past 4 weeks) use of supplements affecting gut microbiota (prebiotics, probiotics, postbiotics, fibres, synbiotics), detoxification pathways (milk thistle, N-acetylcysteine, glutathione) or bile acid metabolism (e.g. psyllium husk)\n* Current or recent (past 2 weeks) consumption of prohibited foods, including probiotic yoghurts\n* Considered by the investigator unlikely to comply with study requirements\n* Current participation in another clinical study, or insufficient time elapsed since a previous experimental study",true,"MALE","18 Years",{"count":138,"type":139},70,"ESTIMATED","INTERVENTIONAL",[142],"NA","This study is designed to evaluate the effect of a probiotic dietary supplement containing Streptococcus salivarius on serum PFAS levels in male firefighters with documented occupational PFAS exposure, following twice-daily use over a 12-week period.",[145,146],"Environmental Exposure","PFAS Exposure",[148,149,150,151,152,153,154,155,156,157],"Cross-over study","Serum PFAS levels","Gut Microbiome","Streptococcus salivarius","Dietary Supplement","Probiotic","Occupational Exposure","Firefighters","Forever Chemicals","Per- and Polyfluoroalkyl Substances","2026-10-07",{"date":160,"type":161},"2026-10-08","ACTUAL",{"date":160,"type":161},{"date":164,"type":139},"2027-11-01",{"name":5,"class":6},1]