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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07226440
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Firefighter
  • Occupational Exposure to Chemicals
  • Toxicant Exposure

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Mar 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Colesevelam first
    Participants randomized to this arm will receive colesevelam, taking 3 tablets twice daily for 12 weeks, followed by a 2-week washout period, and then 12 weeks of matching placebo tablets taken on the same schedule. Both the study drug and the placebo will be provided in identical-appearing bottles to maintain blinding.
  • Placebo Comparator: Placebo first
    Participants randomized to this arm will receive placebo tablets, taking 3 tablets twice daily for 12 weeks, followed by a 2-week washout period, and then 12 weeks of colesevelam (3 tablets twice daily). Both the study drug and the placebo will be provided in identical-appearing bottles to maintain blinding.

Primary Outcome Measure

Retention [ Time Frame: Enrollment to Week 27 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Osher Center for Integrative HealthSan FranciscoCalifornia94115
Leena Pandya, ND
[email protected]
Ashley E Mason, PhD (PRINCIPAL_INVESTIGATOR)
Leena S Pandya, ND (PRINCIPAL_INVESTIGATOR)
Rick M Hecht, MD (SUB_INVESTIGATOR)
Wendy Hartogensis, PhD, MPH (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
UCSF Osher Center for Integrative Health· San Francisco, CA

Related Studies