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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Rhode Island
Study ID
NCT07592858
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Apr 30, 2029
Completion
Sep 29, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Colesevelam
    Oral Colesevelam (3 x 625 mg tablets daily) for 12 weeks
  • Placebo Comparator: Placebo
    Oral placebo (3 x 250 mg once daily) for 12 weeks

Primary Outcome Measure

PFAS content [ Time Frame: 24 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Robley Rex VA Medical CenterLouisvilleKentucky40245
Matthew Cave, MD
[email protected]
5028526189
Matthew Cave, MD (PRINCIPAL_INVESTIGATOR)
VA Maine Healthcare SystemAugustaMaine04330-
VA Maine Healthcare SystemAugustaMaine04330
Rodney Sparks, MD
[email protected]
(207) 623-8411
Vanessa Knipping, MSACN
[email protected]
(207) 623-8411
Rodney Sparks, MD (PRINCIPAL_INVESTIGATOR)
Angela Slitt, PhD (SUB_INVESTIGATOR)

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