A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study Evaluating a Dietary Supplement Supporting Natural Elimination Processes in Male Firefighters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in serum linear perfluorooctane sulfonic acid (n-PFOS)
研究概览
简要总结
This study is designed to evaluate the effect of a probiotic dietary supplement containing Streptococcus salivarius on serum PFAS levels in male firefighters with documented occupational PFAS exposure, following twice-daily use over a 12-week period.
详细描述
This randomized, placebo-controlled, double-blind, crossover pilot study will use serum PFAS measurements, questionnaires and stool sample analyses to evaluate changes in PFAS levels, gastrointestinal symptoms and fatigue with a probiotic dietary supplement compared to a placebo. Each crossover period will last 12 weeks, separated by a four-week washout period. The study will consist of eight study visits: Screening Visit, Period 1 Baseline Visit (Day 0), Day 42 Call, Period 1 Day 84 Visit, Day 98 Call, Period 2 Baseline Visit (Day 112), Day 156 Call, and Period 2 Day 196 Visit.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 基础科学
- 盲法
- 三盲 (受试者、研究者、结局评估者)
盲法说明
The Sponsor is also blinded to treatment allocation. The randomization list is prepared by a statistician not involved in the conduct of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- Able to give written informed consent
- Male firefighter with previous career exposure to PFAS
- BMI between 18.5 and 35 kg/m²
- Serum PFOS level ≥5 ng/mL at screening
- Willing to consume the study product daily for the duration of the study
排除标准
- History of drug and/or alcohol abuse (>15 standard drinks per week)
- Food allergy, intolerance or dietary restriction that, in the opinion of the investigator, would preclude consumption of the study product
- Blood donation within the past 3 months
- Current smoker of >20 cigarettes per day, or former smoker with a history of ≥20 cigarettes per day who quit within 6 months prior to Visit 1
- Any significant acute or chronic health condition that would prevent participation, pose a risk, or confound interpretation of results, including: diagnosed gastrointestinal disorders (irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, ulcerative colitis, coeliac disease, or other chronic diarrhoeal disorders); uncontrolled medical conditions; history of chronic kidney or liver disease; chronic inflammatory or autoimmune disease; history of gastrointestinal surgery; hospitalisation within the past 3 months
- Current or recent (past 12 weeks) use of medications affecting bile acid metabolism (e.g. bile acid sequestrants, fibrates) or antibiotics
- Current or recent (past 4 weeks) use of supplements affecting gut microbiota (prebiotics, probiotics, postbiotics, fibres, synbiotics), detoxification pathways (milk thistle, N-acetylcysteine, glutathione) or bile acid metabolism (e.g. psyllium husk)
- Current or recent (past 2 weeks) consumption of prohibited foods, including probiotic yoghurts
- Considered by the investigator unlikely to comply with study requirements
- Current participation in another clinical study, or insufficient time elapsed since a previous experimental study
研究组 & 干预措施
Sequence A: Study Product then Placebo
Participants consume the probiotic dietary supplement (one capsule twice daily) for 84 days, followed by a 28-day washout, then placebo (one capsule twice daily) for 84 days.
干预措施: Streptococcus salivarius 46-SL1 (Dietary Supplement)
Sequence A: Study Product then Placebo
Participants consume the probiotic dietary supplement (one capsule twice daily) for 84 days, followed by a 28-day washout, then placebo (one capsule twice daily) for 84 days.
干预措施: Placebo (Dietary Supplement)
Sequence B: Placebo then Study Product
Participants consume placebo (one capsule twice daily) for 84 days, followed by a 28-day washout, then the probiotic dietary supplement (one capsule twice daily) for 84 days.
干预措施: Streptococcus salivarius 46-SL1 (Dietary Supplement)
Sequence B: Placebo then Study Product
Participants consume placebo (one capsule twice daily) for 84 days, followed by a 28-day washout, then the probiotic dietary supplement (one capsule twice daily) for 84 days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in serum linear perfluorooctane sulfonic acid (n-PFOS)
时间窗: Baseline (Day 0) to Day 84 of each intervention period
Change in serum n-PFOS concentration (ng/mL) from baseline to end of each 84-day intervention period, comparing the dietary supplement with placebo.
次要结局
- Change in pre-specified serum PFAS levels(Baseline (Day 0) to Day 84 of each intervention period)
- Change in composite serum PFAS measure(Baseline (Day 0) to Day 84 of each intervention period)
- Change in gastrointestinal symptoms (GSRS)(Baseline (Day 0) to Day 84 of each intervention period)
- Change in fatigue (MFIS)(Baseline (Day 0) to Day 84 of each intervention period)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07846371
- 其他研究编号
- CB-AFCRO202-2026-10
日期
- 首次提交
- (7天前)
- 首次发布
- (昨天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Individual participant data will not be shared, as participant consent does not cover external data sharing and the dataset contains commercially confidential information. Aggregate results will be reported.