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NCT07592858 · ClinicalTrials.gov registry record · Phase 2
Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans Study
A Phase 2 study, sponsored by University of Rhode Island.
- Not yet
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT07592858 is a Phase 2 study that has not yet begun recruiting, run by University of Rhode Island. The registered enrollment target is 50 participants.
The verdict
NCT07592858, a Phase 2 study, has not yet begun recruiting, sponsored by University of Rhode Island.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Colesevelam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2029-09-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07592858
The ClinicalTrials.gov registry entry for NCT07592858 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rhode Island, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07592858 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07592858 about?
NCT07592858 is a clinical study titled "Use of Bile Acid Binding Resins to Decrease PFAS Levels Via Colesevalem in Veterans 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 ...
What is the current status of trial NCT07592858?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2026-07-01. Estimated completion is 2029-09-29.
What interventions are being tested in trial NCT07592858?
The interventions under investigation include: Placebo (DRUG), Colesevelam (DRUG).
Who is sponsoring clinical trial NCT07592858?
This trial is sponsored by University of Rhode Island, which has 29 total clinical trials registered on ClinicalTrials.gov.
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