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Completed

NCT Number: NCT04258059

Wells and Enteric Disease Transmission Trial (WET - Trial)

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.

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Key information

Conditions

Gastrointestinal Infection Infections Respiratory Tract Diseases Respiratory Tract Infections Respiratory Viral Infection

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

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Active household UV water treatment device

Device

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

Inactive household UV water treatment device

Device

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

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 (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.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Sep 9, 2025

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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