水井和肠道疾病传播试验(WET - 试验)
水井和肠道疾病传播 - 随机对照试验(WET-试验)
Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Pennsylvania
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Philadelphia、Pennsylvania、美国、19122
- Temple University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Household must rely on a private groundwater supply (private well or spring)
- Child must be over six months and under 4 years old at enrollment so that they will be under five years of age for the duration of the 12-month study period.
- >75% of the water the child consumes must be tap water untreated by any treatment device capable of microbial water treatment. Proportion is estimated by the parent and includes water used to make juice or formula.
- Child must be a full-time resident of the home, defined as living in the home for five or more days every week. The intervention is administered at the household level; therefore the child must reside at home and be regularly exposed to the intervention.
Exclusion Criteria:
- Child has a chronic, gastrointestinal condition (e.g., Crohn's disease), which may complicate differentiation between signs and symptoms of gastrointestinal illness associated with drinking water and those of the pre-existing condition.
- Child is immunocompromised, which may result in increased susceptibility to waterborne illness. Daily oral steroids also considered an exclusion criteria due to their associated immunosuppressive effects.
- Parents are unable to submit data through short message service (SMS) text messages (smartphone was not required).
- Household treats their water for microbiological contamination at point-of-entry or point-of-use.
In the case where multiple children met the eligibility criteria, the youngest eligible child was enrolled. Records were maintained on the recruitment process documenting reasons for eligibility and those that declined to participate in the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Active UV Device
A household water treatment device with a lamp emitting germicidal UV. The device will be operated at 50 millijoule per square centimeter to treat >99.9% of all bacteria, protozoa, and most viruses in water supplies. |
This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home. |
|
假比较器:Inactive UV Device
A device that appears identical to the active comparator device except the lamp will not emit germicidal UV. |
This sham device will use a lamp not emitting germicidal UV. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incident gastrointestinal illness
大体时间:12 months
|
The investigators will collect data on the presence of gastrointestinal illness symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (incidence, severity, duration, diarrhea, vomiting, coughing, etc.), febrile episodes, as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Incident gastrointestinal illness (GI) is defined by the reporting of a minimum of three episodes of diarrhea or vomiting in a 24 hour period. Each illness will be considered distinct when separated by ≥ 6 symptom-free days. |
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acute respiratory illness (ARI)
大体时间:12 months
|
As some waterborne pathogens (e.g., enterovirus and adenovirus) manifest with respiratory symptoms, we also captured ARI episodes, defined as: nasal congestion, nasal discharge, sore throat, mouth sores, or cough lasting at least one day, in the absence of another explanation such as isolated cough with a known history of asthma. Each incidence of respiratory infection was considered a unique illness event when preceded by ≥six symptom-free days. |
12 months
|
合作者和调查者
调查人员
- 首席研究员:Heather Murphy, PhD、Assistant Professor
出版物和有用的链接
一般刊物
- Hellard ME, Sinclair MI, Harris AH, Kirk M, Fairley CK. Cost of community gastroenteritis. J Gastroenterol Hepatol. 2003 Mar;18(3):322-8. doi: 10.1046/j.1440-1746.2003.02959.x.
- Johnson TD, Belitz K, Lombard MA. Estimating domestic well locations and populations served in the contiguous U.S. for years 2000 and 2010. Sci Total Environ. 2019 Oct 15;687:1261-1273. doi: 10.1016/j.scitotenv.2019.06.036. Epub 2019 Jun 6.
- Roberts JA, Cumberland P, Sockett PN, Wheeler J, Rodrigues LC, Sethi D, Roderick PJ; Infectious Intestinal Disease Study Executive. The study of infectious intestinal disease in England: socio-economic impact. Epidemiol Infect. 2003 Feb;130(1):1-11. doi: 10.1017/s0950268802007690.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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