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NOT YET RECRUITING
NCT07592858
PHASE2

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

Sponsor: University of Rhode Island

View on ClinicalTrials.gov

Summary

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.

Official title: Use of Bile Acid Binding Resins to Decrease Systemic Per- and Polyfluoroalkyl Substance (PFAS) Levels and Improve Serum Lipid Profiles in Veterans: PFAS Reduction in Veterans Via Colesevalem Study (PAVERS) Study

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07-01

Completion Date

2029-09-29

Last Updated

2026-05-18

Healthy Volunteers

Yes

Interventions

DRUG

Colesevelam

A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks

DRUG

Placebo

A double-blind randomized controlled trial with an extended open phase to test the use of oral Colesevelam

Locations (3)

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