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

ConditionsToxicant Exposure Firefighter Occupational Exposure to Chemicals

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexMale

Age18+

SponsorUniversity of California, San Francisco

About this trial

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 criteria

Qualifiers

Male firefighter, active or retired

California resident

Age 18 or older

English-speaking

Disqualifiers

Gastroparesis or other severe gastrointestinal motility disorders

Bowel obstruction

History of major gastrointestinal tract surgery

Dysphagia or difficulty swallowing (due to tablet size)

Trial design

Treatments tested in this trial

Colesevelam
Placebo

Treatment groups

50 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov