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NCT Number: NCT07836023

PFAS Clinical Trial

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.

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Key information

Conditions

Environmental Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

The objective of this study is to assess whether cholestyramine, a bile acid sequestrant approved for the treatment of high cholesterol, can reduce the body burden of per- and polyfluoroalkyl substances (PFAS). PFAS are persistent chemicals that can accumulate in the body and have been associated with adverse health effects.

The study will enroll 300 adults from Rome and Calhoun, Georgia. Participants will complete four study visits which will include providing blood, urine, and fecal samples, as well as answering questionnaires. As part of the study, participants will be prescribed cholestyramine therapy for either one, two, three, or four months (up to 120 days) using a stepped-wedge trial study design. The study duration is 4 months for each participant.

Biospecimens will be stored for future research use. Written informed consent will be obtained from all participants before any study procedures are performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Residence in Floyd or Gordon County, Georgia
  • Residence in the study area for at least 5 years
  • No plans to relocate from the study area within the next 6 months
  • Able to communicate in English
  • Not currently pregnant
  • Primarily drinks tap water

Exclusion criteria

  • Taken antibiotics in the last three months
  • Currently taking a BAS or drugs with known contraindications, bowel or stomach resections, malabsorptive conditions, documented celiac or irritable bowel disease
  • Stage 4 or higher chronic kidney disease
  • Hospitalization with acute condition in the last three months
  • History of malignant carcinoma.

Treatment and study plan

Cholestyramine

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).

Other names: Cholestyramine resin

Centrum

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.

Other names: Multivitamin, Centrum Adult Multivitamin

Primary outcomes

  1. Serum NASEM ΣPFAS concentration

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

    The summed serum PFAS concentration (in ng/mL) according to a definition recommended by the National Academies of Sciences, Engineering, and Medicine (NASEM) will be measured.

Secondary outcomes

  1. Shannon diversity index

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

    The Shannon Diversity Index will be used to assess the diversity of microorganisms in the gut microbiome. The measure considers both the number of different types of microorganisms present and their relative abundance. Higher values indicate greater microbial diversity.

  2. Species richness

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

    Species richness will be used to assess the number of different microbial species detected in the gut microbiome. Higher values indicate a greater variety of microbial species.

  3. Functional pathway abundance

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

    Functional pathway abundance will be used to assess the relative abundance of microbial genes associated with specific biological functions or metabolic pathways in the gut microbiome.

  4. Strain richness

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

    The number of distinct microbial strains detected in the gut microbiome. Higher values indicate a greater variety of microbial strains.

  5. Taxa abundance

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

    Taxa abundance will be used to assess changes in the relative abundance of specific groups of microorganisms in the gut microbiome.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Unbinding Forever Chemicals: an Intervention Trial for Reducing PFAS Body Burden and Assessing the Role of the Microbiome

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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