Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study

The goal of this study is to test the efficacy and feasibility of Colesevelam administration (50% of the recommended dose) to reduce serum PFAS concentration in the Veteran population who have serum PFAS levels that exceed the National Academies Science criteria (PFASsix \> 20 ng/ml) using a double blind-placebo controlled study. Based on PFAS prevalence in serum samples, we anticipate recruiting up to n=500 Veterans to meet the goal of n=50 study participants to receive intervention or placebo. The primary outcome will be initial and final PFAS content in serum (total and 7 individual PFAS). The secondary outcome will be initial and final serum biomarkers related to lipid metabolism. As an exploratory aspect to the proposal, we will also measure fecal PFAS, bile acids, and microbial diversity to examine associations between PFAS content and bile acid levels and microbiome. Fecal PFAS, bile acid content, and microbiome may also be measured.

NCT Number	NCT07592858
Lead Sponsor	University of Rhode Island Collaborators: Louisville VA Medical Center, University of Louisville, Congressionally Directed Medical Research Programs
Conditions	PFAS, Environmental Exposures, Occupational Exposure to Chemicals, Military Exposure, Burn Pit Exposure, Forever Chemicals, Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia, Hyperlipidemia (E.G., Hypercholesterolemia)
Enrollment	50 participants
Start Date	2026-07-01
Primary Completion	2029-04-30 (estimated)
Study Completion	2029-09-29 (estimated)
Updated on ClinicalTrials.gov	2026-05-18