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RECRUITING
NCT07226440
PHASE1/PHASE2

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Official title: Assessing the Impact of a Bile Acid Sequestrant on Serum PFAS Levels in Highly Exposed Individuals

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-01

Completion Date

2028-12

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

Colesevelam

Colesevelam in 625-mg tablets. Participants will take 3 tablets orally, twice daily (total daily dose 3.75 g) for 12 weeks.

DRUG

Placebo

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)

UCSF Osher Center for Integrative Health

San Francisco, California, United States