Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
Starting soon · Phase 2 · Has a placebo group
Conditions studied: PFAS, Environmental Exposures, Occupational Exposure to Chemicals, Military Exposure, Burn Pit Exposure, Forever Chemicals, Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia, Hyperlipidemia (E.G., Hypercholesterolemia)
In brief
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.
Key facts
- Study ID
- NCT07592858
- Run by
- University of Rhode Island
- People needed
- 50
- Starts
- 2026-07-01
- Expected to finish
- 2029-09-29
- Last updated by the study team
- 2026-05-18
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- Robley Rex VA Medical Center — Louisville, Kentucky, United States
- VA Maine Healthcare System — Augusta, Maine, United States
- VA Maine Healthcare System — Augusta, Maine, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.