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New treatment option for Toxicant Exposure
Official title Examining a Novel Gastrointestinal Intervention to Negate Environmental Toxicants (ENGINE)
ClinicalTrials.gov ID: NCT07226440
What this study is testing
What is Colesevelam?
Colesevelam is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for toxicant exposure.
Also referred to as Welchol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male firefighter, active or retired
- California resident
- Age 18 or older
- English-speaking
- Access to a reliable internet connection
You likely 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.