PFAS Clinical Trial

NCT07836023 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 2026P001556
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Environmental Exposure

Keywords

PFAS; Perfluoroalkyl Substances; Polyfluoroalkyl Substances; Cholestyramine; Bile Acid Sequestrant; Microbiome

Outcome Measures

Primary Outcomes (1)

• Serum NASEM ΣPFAS concentration

  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.

  Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

Secondary Outcomes (5)

• Shannon diversity index

  Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

• Species richness

  Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

• Functional pathway abundance

  Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

• Strain richness

  Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

• Taxa abundance

  Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention

Study Arms (1)

Cholestyramine therapy Group

EXPERIMENTAL

Participants will receive cholestyramine therapy for one, two, three, or four months (up to 120 days in total).The dose will be escalated from 4 g/day during Week 1 to 8 g/day during Week 2 and 12 g/day thereafter for their remaining weeks while on the intervention (between 2-14 weeks depending on the study arm). Participants will additionally be given a bottle of Centrum-brand multivitamins 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).

Drug: Cholestyramine; Drug: Centrum

Interventions

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).

Also known as: Cholestyramine resin

Cholestyramine therapy Group

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.

Also known as: Multivitamin, Centrum Adult Multivitamin

Cholestyramine therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Cholestyramine Resin; Geritol

Intervention Hierarchy (Ancestors)

Polystyrenes; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stephanie Eick, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Eick, PhD

CONTACT

404-829-4813; ngapfas@emory.edu

Alina Merceron, MPH

CONTACT

alina.merceron@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped wedge randomized control trial

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)