Cambiotics ApS
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.
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.
Inclusion Criteria: * Able to give written informed consent * Male firefighter with previous career exposure to PFAS * BMI between 18.5 and 35 kg/m² * Serum PFOS level ≥5 ng/mL at screening * Willing to consume the study product daily for the duration of the study Exclusion Criteria: * History of drug and/or alcohol abuse (\>15 standard drinks per week) * Food allergy, intolerance or dietary restriction that, in the opinion of the investigator, would preclude consumption of the study product * Blood donation within the past 3 months * Current smoker of \>20 cigarettes per day, or former smo…
One capsule (\~400 mg live probiotic) consumed twice daily with water, in the morning with breakfast and with the evening meal, for 84 days.
Matching placebo capsule containing microcrystalline cellulose, magnesium stearate and silicon dioxide, consumed twice daily with water for 84 days.
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