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

NCT07226440 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Toxicant Exposure
  • Firefighter
  • Occupational Exposure to Chemicals

Interventions

DRUG

Colesevelam

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

DRUG

Placebo

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.

Sponsors & Collaborators

Principal Investigators

  • Ashley E Mason, PhD · University of California San Francisco, Osher Center for Integrative Health

  • Leena Pandya, ND · University of California San Francisco, Osher Center for Integrative Health

  • Sarah Fisher, MS · University of California San Francisco, Osher Center for Integrative Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226440 on ClinicalTrials.gov