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

NCT07592858 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • PFAS
  • Environmental Exposures
  • Occupational Exposure to Chemicals
  • Military Exposure
  • Burn Pit Exposure
  • Forever Chemicals
  • Hyperlipidemias, Hypercholesterolemia, Mixed Dyslipidemia
  • Hyperlipidemia (E.G., Hypercholesterolemia)

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

Sponsors & Collaborators

  • Louisville VA Medical Center

    collaborator FED

  • University of Louisville

    collaborator OTHER

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • University of Rhode Island

    lead OTHER

Principal Investigators

  • Angela Slitt, PhD · The University of Rhode Island

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2029-04-30
Completion
2029-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07592858 on ClinicalTrials.gov