Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
MALE
NCT07226440

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

Led by University of California, San Francisco · Updated on 2026-04-24

50

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male firefighter, active or retired
  • California resident
  • Age 18 or older
  • 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 (e.g., duration of firefighting service, prior NASEM-7 result greater than or equal to 10 ng/mL)
Not Eligible

You will not qualify if you...

  • 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.
  • Unalterable plans to donate blood or plasma during the study participation period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCSF Osher Center for Integrative Health

San Francisco, California, United States, 94115

Actively Recruiting

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Research Team

A

Ashley Mason, PhD

CONTACT

L

Leena Pandya, ND

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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