Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study (NCT07592858) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
United States50 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
25 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.