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Active, Not Recruiting

NCT Number: NCT04826991

Wells and Enteric Disease Transmission

Approximately 40 million people in the US are served by private, and frequently untreated, wells. Our best estimate is that 1.3 million cases of gastrointestinal illnesses (GI) per year are attributed to consuming water from untreated private wells in the US, but in reality, there are no robust epidemiological data that can be used to estimate cases of GI attributable to these sources. We propose the first randomized controlled trial (RCT) to estimate the burden of GI associated with private well water. We will test if household treatment of private well water by ultraviolet light (UV) vs. sham (inactive UV device) decreases the incidence of GI in children under 5. We will also examine the presence of viral, bacterial, and protozoan pathogens in stool and well water from participants. These data will fill a knowledge gap on sporadic GI associated with federally-unregulated private water supplies in the US.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diarrhea Gastrointestinal Infection Infections Pathological Conditions, Signs and Symptoms Respiratory Viral Infection Signs and Symptoms Signs and Symptoms, Digestive Waterborne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University

Philadelphia, Pennsylvania, 19122, United States

About this study

Investigators will conduct a triple-blinded randomized controlled trial of a whole-home UV water treatment device in southeastern Pennsylvania. Participating families will be randomized to receive an active UV device or a sham (inactive) UV device. Following the installation of the device, participants will be followed for one year. During that year, participants will respond to weekly text messages to report the presence of symptoms associated with gastrointestinal and respiratory illness in their children. Upon reporting symptoms, participants will complete an illness questionnaire on details regarding the illness and other potential exposure events. A subset of participants will submit groundwater samples as well as stool and saliva samples from their children. Water and stool samples will be analyzed for common waterborne pathogens. Saliva samples will be analyzed for immunoconversions to common waterborne pathogens (exploratory aim).

Under the guidance of an interdisciplinary advisory committee we will execute the following aims:

Aim 1- Quantify the incidence rate of endemic childhood GI associated with consuming untreated private well water and compare that to the incidence rate of consuming well water treated by UV.

Aim 1a- Construct a Quantitative Microbial Risk Assessment (QMRA) using water quality data we collect to estimate the risk of childhood GI associated with consuming untreated private well water and compare the incidence from the risk model to the incidence we calculate in Aim 1.

Aim 2- Identify, quantify and compare viral, bacterial and protozoan pathogens in stool of children consuming UV treated or untreated (sham) private well water (including both asymptomatic and symptomatic cases).

Aim 3- Explore the presence of pathogens in untreated well water and stool samples of children consuming untreated private well water (sham group only).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child resides in Adams, Berks, Bucks, Carbon, Chester, Columbia, Cumberland, Dauphin, Delaware, Lackawanna, Lancaster, Lebanon, Lehigh, Luzerne, Monroe, Montgomery, Montour, Northumberland, Northampton, Perry, Pike, Schuylkill, Wayne, Wyoming, and York county in Pennsylvania and all counties in New Jersey.
  • Household is served by a private well
  • Participant child is under the age of 5 (under 4 at time of enrollment), who is a full-time resident of the home and drinks untreated well water
  • Parent/guardian has access to a phone with texting capabilities

Exclusion criteria

  • Child participant is immunocompromised
  • Child participant has a chronic gastrointestinal condition
  • Child takes daily oral steroids
  • Household treats water for microbiological contamination before consumption
  • Child exclusively drinks bottled water

Treatment and study plan

Active UV Device

Device

Active water treatment system

Inactive UV Device

Device

Inactive water treatment system

Primary outcomes

  1. Incident gastrointestinal illness

    Time frame: 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 (type, incidence, severity, duration, etc.), 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.

Secondary outcomes

  1. Acute respiratory infection

    Time frame: 12 months

    The investigators will collect data on the presence of acute respiratory infection symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (type, incidence, severity, duration, etc.) as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Acute respiratory infection is defined by the reporting of nasal congestion/discharge, sore throat or mouth sores, or cough lasting at least one day, in the absence of another explanation, such as isolated cough without nasal symptoms in known reactive airways disease. Each illness will be considered distinct when separated by ≥ 6 symptom-free days.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Wells and Enteric Disease Transmission - A Randomized Trial of Children Supplied Drinking Water From Private Wells (WET-Trial)

Acronym: WET

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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