💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Male firefighter, active or retired
* California resident
* Age 18 or older
* English-speaking
* Access to a reliable internet connection
* Willing to attend 3 in-person study visits in the San Francisco Bay Area over about 6.5 months
* Willing to receive weekly text message reminders to complete online surveys
* Willing to complete a mail-based, at-home finger-prick blood test
* Willing to take 3 tablets (each tablet about the size of a multivitamin) orally twice daily for a total of 6 months
* 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/mL)
Exclusion Criteria:
* Gastroparesis or other severe gastrointestinal motility disorders
* Bowel obstruction
* History of major gastrointestinal tract surgery
* Dysphagia or difficulty swallowing (due to tablet size)
* History of hypertriglyceridemia (triglycerides exceeding 500 mg/dL)
* History of hypertriglyceridemia-induced pancreatitis
* Type 1 or 2 diabetes
* History of fat-soluble vitamin deficiencies, i.e., vitamins A, D, E, or K
* Phenylketonuria
* History of known bleeding/clotting disorders
* Medications or treatments that may impact the excretion of PFAS, such as activated charcoal, other bile acid sequestrants, chelation therapies, etc.
* Unalterable plans to donate blood or plasma during the study participation period
HealthTeky