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
University of California, San Francisco
50 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria12
- 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
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Interventions
Colesevelam in 625-mg tablets. Participants will take 3 tablets orally, twice daily (total daily dose 3.75 g) for 12 weeks.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07226440