PFAS Clinical Trial
ConditionEnvironmental Exposure
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cholestyramine
DrugParticipants 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
DrugA 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Cholestyramine therapy GroupExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline, Day 30, Day 60, Day 90, and Day 120 post-interventionSecondary outcomes
1
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.
Time frame
Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention2
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.
Time frame
Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention3
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.
Time frame
Baseline, Day 30, Day 60, Day 90, and Day 120 post-intervention4
Strain richness
The number of distinct microbial strains detected in the gut microbiome. Higher values indicate a greater variety of microbial strains.
Time frame
Baseline, Day 30, Day 60, Day 90, and Day 120 post-interventionSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: