Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Toxicant Exposure, Firefighter, Occupational Exposure to Chemicals

In brief

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.

Key facts

Study ID

NCT07226440

Run by

University of California, San Francisco

People needed

50

Starts

2026-03-01

Expected to finish

2028-12-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UCSF Osher Center for Integrative Health — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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