Home › NCT07226440
Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)
RecruitingPhase 1/2
Assessing the Impact of a Bile Acid Sequestrant on Serum PFAS Levels in Highly Exposed Individuals
Who can join
Ages 18 and older · Men
Full eligibility criteria
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
About the study
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.
What is being tested
- Colesevelam (drug)
- Placebo (drug)
Sponsor: University of California, San Francisco · Participants: 50 · Started: Mar 1, 2026
Contact the study team
- Ashley Mason, PhD · Phone: 415-514-6820
- Leena Pandya, ND · Phone: 415-502-1619
Official record on ClinicalTrials.gov — NCT07226440
Locations in the U.S.
| California | UCSF Osher Center for Integrative Health, San Francisco |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.