NCT07592858Not yet recruitingPhase 2
Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
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
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- University of Rhode Island
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07592858
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 1 Jul 2026 to the primary completion date, 30 Apr 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 25 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Maine Healthcare System Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Robley Rex VA Medical Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.