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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

Sponsor: University of California, San Francisco · Participants: 50 · Started: Mar 1, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07226440

Locations in the U.S.

CaliforniaUCSF 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.