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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25-65
SponsorUniversity of Rhode Island

About this trial

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.

Eligibility criteria

Qualifiers

Male or female Veterans aged 25- 65 who have serum PFAS >20 ng/ml exceeding National Academy of Science guidance.

Written informed consent will be obtained.

Outpatient.

Agreeable to participate in sharable data and biorepository.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Colesevelam
  • Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Rhode Island

Lead sponsor

Louisville VA Medical Center

Collaborator

University of Louisville

Collaborator

Congressionally Directed Medical Research Programs

Collaborator