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Environmental ExposureMicrobiomeDrugPhase 2

What this study is

The purpose of this study is to evaluate whether treatment with cholestyramine for either one, two, three, or four months (up to 120 days), meaningfully influences per- and polyfluoroalkyl substances (PFAS) removal from the body.

What's being tested

  • Cholestyramine

    Intervention · DRUG

    Participants will be randomized to be prescribed cholestyramine therapy for one, two, three, or four months (up to 120 days in total). Participants will be prescribed cholestyramine at a dose of 4 grams daily (one dose) for the first week, 8 grams daily (two doses) for the second week, and 12 grams daily (three doses) for their remaining weeks while on the intervention (between 2-14 weeks depending on the study arm).

  • Centrum

    Intervention · DRUG

    A bottle of Centrum-brand multivitamins will be provided at the first visit, with the option to take these vitamins daily as indicated on the multivitamin packing, while they are participating in the study (up to 120 days). The multivitamins are recommended as cholestyramine can lead to low levels of vitamins after long-term use.

Study details

Official title
Unbinding Forever Chemicals: an Intervention Trial for Reducing PFAS Body Burden and Assessing the Role of the Microbiome
Sponsor
Emory University
Conditions
Environmental Exposure
Enrolling
300 people
Starts
2026-11
Est. completion
2030-06
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗