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

a study on Toxicant Exposure Firefighter Occupational Exposure to Chemicals

Summary

Eligibility
for males ages 18-64 (full criteria)
Location
at San Francisco 5391959, California 5332921
Dates
study started
study ends around
Principal Investigator
by Ashley E Mason, PhDLeena Pandya, ND
Headshot of Ashley E Mason
Ashley E Mason

Description

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

Details

Firefighters experience elevated exposure to per- and polyfluoroalkyl substances (PFAS) through firefighting foams, turnout gear, and dust in fire stations. PFAS persist in the body due to their long biological half-lives, leading to bioaccumulation and raising concern for adverse effects on hormone regulation, immune function, reproduction, and cancer risk. Despite growing awareness, there are no approved treatment options to reduce PFAS levels in humans. Bile acid sequestrants, such as colesevelam, bind bile acids in the gastrointestinal tract and may interrupt enterohepatic recirculation of PFAS, thereby enhancing elimination. Observational studies and one small randomized trial suggest that bile acid sequestrants can meaningfully reduce PFAS levels. This trial will evaluate the feasibility, adherence, and acceptability of colesevelam in male firefighters with elevated PFAS, while exploring its effects on serum PFAS concentrations and urine environmental toxicant and mold mycotoxin levels.

Keywords

Toxicant Exposure, Firefighter, Occupational Exposure to Chemicals, Per- and polyfluoroalkyl substances, PFAS, Firefighters, Occupational exposure, Bile acid sequestrants, Colesevelam, Progressive Encephalomyelitis with Rigidity, Colesevelam Hydrochloride, Colesevelam first

Eligibility

You can join if…

Open to males ages 18-64

  • Male firefighter
  • California resident
  • Age 18-64
  • Full-time, active-duty (fire suppression and/or arson investigation) firefighter for the past 10 consecutive years
  • 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

You CAN'T join 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.
  • More than one blood or plasma donation in the past 12 months and/or unalterable plans to donate blood or plasma during the study participation period
  • Use of clomiphene, testosterone, human chorionic gonadotropin, anabolic steroids, anastrozole or any other substances that may impact testosterone levels in males

Location

  • UCSF Osher Center for Integrative Health
    San Francisco 5391959 California 5332921 94115 United States

Lead Scientists at UCSF

  • Ashley E Mason, PhD
    Associate Professor, Psychiatry, School of Medicine. Authored (or co-authored) 83 research publications. Research interests: Non-pharmacologic interventions for depression and insomnia · Clinical Depression · Firefighter Health · Insomnia
  • Leena Pandya, ND
    Associate Specialist, Osher Center, School of Medicine. Authored (or co-authored) 13 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07226440
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated