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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

  • 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.

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.

Secondary outcomes

  1. Acute respiratory illness (ARI)

    Time frame: 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.

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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 21, 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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