Environmental ExposurePhase 2NCT07836023
PFAS Clinical Trial
A Phase 2 study testing Cholestyramine and Centrum in people with Environmental Exposure, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Cholestyramine and Centrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alina Merceron, MPH contact
United States1 site
Emory University
Atlanta, Georgia, 30322
Stephanie Eick, PhD, stephanie.marie.eick@emory.edu
About this study
Official title: Unbinding Forever Chemicals: an Intervention Trial for Reducing PFAS Body Burden and Assessing the Role of the Microbiome
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.
Read the detailed description
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.
- Conditions
- Environmental Exposure
- Being tested
- Cholestyramine, Centrum
- Keywords
- PFAS, Perfluoroalkyl Substances, Polyfluoroalkyl Substances, Cholestyramine, Bile Acid Sequestrant, Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholestyramineDrug
Also called Cholestyramine resin
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).
CentrumDrug
Also called Multivitamin, Centrum Adult Multivitamin
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Cholestyramine; Drug: Centrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Secondary outcomes (5)
Shannon diversity index
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.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Species richness
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.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Functional pathway abundance
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.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Strain richness
The number of distinct microbial strains detected in the gut microbiome. Higher values indicate a greater variety of microbial strains.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Taxa abundance
Taxa abundance will be used to assess changes in the relative abundance of specific groups of microorganisms in the gut microbiome.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stepped wedge randomized control trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Eick, Emory University
- Investigators
- Stephanie Eick, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836023
- Sponsor's protocol ID
- 2026P001556
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unbinding Forever Chemicals: an Intervention Trial for Reducing PFAS Body Burden and Assessing the Role of the Microbiome
- ClinicalTrials.gov ID
- NCT07836023
- Acronym / sponsor ID
- 2026P001556
- Conditions
- Environmental Exposure
- Keywords
- PFAS, Perfluoroalkyl Substances, Polyfluoroalkyl Substances, Cholestyramine, Bile Acid Sequestrant, Microbiome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Cholestyramine therapy Group | Experimental | Drug: Cholestyramine, Drug: CentrumParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholestyramineAlso: Cholestyramine resinParticipants 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). | Drug | Cholestyramine therapy Group |
| CentrumAlso: Multivitamin, Centrum Adult MultivitaminA 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. | Drug | Cholestyramine therapy Group |
Primary outcome
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.
5 secondary outcomes
Shannon diversity index
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Species richness
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Functional pathway abundance
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Strain richness
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Taxa abundance
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alina Merceron, MPH contact
Stephanie Eick, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholestyramine and Centrum in people with Environmental Exposure, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Eick, PhD (404-829-4813, ngapfas@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum NASEM ΣPFAS concentration (time frame: Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.