Unbinding Forever Chemicals: an Intervention Trial for Reducing PFAS Body Burden and Assessing the Role of the Microbiome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serum NASEM ΣPFAS concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cholestyramine therapy Group
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).
干预措施: Cholestyramine (Drug)
Cholestyramine therapy Group
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).
干预措施: Centrum (Drug)
结局指标
主要结局
Serum NASEM ΣPFAS concentration
时间窗: 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.
次要结局
- 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)
研究者
Stephanie Eick
Assistant Professor
Emory University