Colesevelam to lower PFAS chemicals in the blood of Veterans
Tests colesevelam against placebo to lower blood PFAS levels in Veterans.
Plain-language title generated from the registry record
Registry title: Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
Key facts
- Where
- Augusta and Louisville, United StatesSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 65 years old?
Source: NCT07592858, who can take part
Where in United States
- VA Maine Healthcare SystemAugusta, United StatesNo longer taking part
- Robley Rex VA Medical CenterLouisville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Rhode Island
- Trial code
- NCT07592858
- Record updated
- 18 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion:; 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; Exclusion:; Under the age of 25 years; Unable or unwilling to sign the informed consent statement and HIPAA Authorization form; Females who are pregnant (confirmed by urine pregnancy test), nursing or planned pregnancy within study period; Patients with hypertriglyceridemia, vitamin deficient patients, hyperthyroidism and diabetic, pancreatitis and intestinal and bowel obstruction; Be receiving any investigational drug other than Colesevelam or participating in any other investigational study; Significant medical illnesses that may limit the subject's ability to complete follow-up visits, in the opinion of the investigator; Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results; Those with significant cardiovascular disease including treatment with inotropes; Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data; Active substance abuse if this, in the opinion of the investigator, will interfere with the subject's ability to adhere to the study protocol.