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Wells and Enteric Disease Transmission Trial (WET - Trial)

Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04258059
Enrollment
28
Registered
2020-02-06
Start date
2020-06-30
Completion date
2022-05-01
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Infection, Respiratory Viral Infection

Keywords

groundwater, private wells, acute gastrointestinal illness, respiratory infection

Brief summary

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.

Interventions

DEVICEActive household UV water treatment device

This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.

DEVICEInactive household UV water treatment device

This sham device will use a lamp not emitting germicidal UV.

Sponsors

Pennsylvania Department of Health
CollaboratorOTHER_GOV
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
Yes

Inclusion criteria

* Child resides in Berks, Bucks, Chester, Lancaster, Lehigh, or Montgomery County in Pennsylvania * 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 (75% or more of water consumption must be from 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 before consumption (with the exception of water softeners)

Design outcomes

Primary

MeasureTime frameDescription
Incident gastrointestinal illness12 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026