Wells and Enteric Disease Transmission Trial (WET - Trial)

NCT04258059 | Completed

• 1 other identifier: 25665 (Pilot Trial)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Infection; Respiratory Viral Infection

Keywords

groundwater; private wells; acute gastrointestinal illness; respiratory infection

Outcome Measures

Primary Outcomes (1)

• Incident gastrointestinal illness

  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

Study Arms (2)

Active UV Device

ACTIVE COMPARATOR

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.

Device: Active household UV water treatment device

Inactive UV Device

SHAM COMPARATOR

A device that appears identical to the active comparator device except the lamp will not emit germicidal UV.

Device: Inactive household UV water treatment device

Interventions

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.

Active UV Device

Inactive household UV water treatment device DEVICE

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

Inactive UV Device

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Temple University: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (3)

• 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.

  PMID: 12603534 BACKGROUND

• 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.

  PMID: 31412460 BACKGROUND

• 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.

  PMID: 12613740 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Heather Murphy, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Research Professor

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 6, 2020
• Study Start: June 30, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)