Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)
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 groupsLocations
1UCSF Osher Center for Integrative Health94115, San FranciscoCalifornia, United States
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Source ClinicalTrials.gov