NCT07226440 Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)
| NCT ID | NCT07226440 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Toxicant Exposure |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-03-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Ashley E Mason, PhD
PRINCIPAL INVESTIGATOR
University of California San Francisco, Osher Center for Integrative Health
Frequently Asked Questions
Who can join the NCT07226440 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Toxicant Exposure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07226440 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07226440 currently recruiting?
Yes, NCT07226440 is actively recruiting participants. Contact the research team at enginestudy@ucsf.edu for enrollment information.
Where is the NCT07226440 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07226440 clinical trial?
NCT07226440 is sponsored by University of California, San Francisco. The principal investigator is Ashley E Mason, PhD at University of California San Francisco, Osher Center for Integrative Health. The trial plans to enroll 50 participants.