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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: ColesevelamExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFAS content

Reduction PFAS content in serum (total and 7 individual PFAS).

Time frame
24 weeks

Secondary outcomes

1

Serum biomarkers

The secondary outcome will be initial and final serum biomarkers related to lipid metabolism.

Time frame
24 weeks

Other outcomes

1

Exploratory

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.

Time frame
24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rhode Island

Lead sponsor

Louisville VA Medical Center

Collaborator

University of Louisville

Collaborator

Congressionally Directed Medical Research Programs

Collaborator

This trial is not recruiting at the moment. You can still explore other options: