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

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.

Timeline

Start

2026-03-01

Primary completion

2028-12

Completion

2028-12

Publications

• Background Johnson JD, Gibson SJ, Ober RE. Cholestyramine-enhanced fecal elimination of carbon-14 in rats after administration of ammonium [14C]perfluorooctanoate or potassium [14C]perfluorooctanesulfonate. Fundam Appl Toxicol. 1984 Dec;4(6):972-6. doi: 10.1016/0272-0590(84)90235-5.
• Background Mazumder NU, Hossain MT, Jahura FT, Girase A, Hall AS, Lu J, Ormond RB. Firefighters' exposure to per-and polyfluoroalkyl substances (PFAS) as an occupational hazard: A review. Front Mater. 2023;10:10.3389/fmats.2023.1143411. doi: 10.3389/fmats.2023.1143411. Epub 2023 Mar 23.
• Background Young AS, Sparer-Fine EH, Pickard HM, Sunderland EM, Peaslee GF, Allen JG. Per- and polyfluoroalkyl substances (PFAS) and total fluorine in fire station dust. J Expo Sci Environ Epidemiol. 2021 Sep;31(5):930-942. doi: 10.1038/s41370-021-00288-7. Epub 2021 Feb 5.
• Background Lucas K, Gaines LGT, Paris-Davila T, Nylander-French LA. Occupational exposure and serum levels of per- and polyfluoroalkyl substances (PFAS): A review. Am J Ind Med. 2023 May;66(5):379-392. doi: 10.1002/ajim.23454. Epub 2022 Dec 27.
• Background Moller JJ, Lyngberg AC, Hammer PEC, Flachs EM, Mortensen OS, Jensen TK, Jurgens G, Andersson A, Soja AMB, Lindhardt M. Substantial decrease of PFAS with anion exchange resin treatment - A clinical cross-over trial. Environ Int. 2024 Mar;185:108497. doi: 10.1016/j.envint.2024.108497. Epub 2024 Feb 13.
• Background Ducatman A, Luster M, Fletcher T. Perfluoroalkyl substance excretion: Effects of organic anion-inhibiting and resin-binding drugs in a community setting. Environ Toxicol Pharmacol. 2021 Jul;85:103650. doi: 10.1016/j.etap.2021.103650. Epub 2021 Apr 2.
• Background Seyyedsalehi MS, Boffetta P. Per- and Poly-fluoroalkyl Substances (PFAS) Exposure and Risk of Kidney, Liver, and Testicular Cancers: A Systematic Review and Meta-Analysis. Med Lav. 2023 Oct 24;114(5):e2023040. doi: 10.23749/mdl.v114i5.15065.

Drugs

Indications