Wells and Enteric Disease Transmission

NCT04826991 | Active Not Recruiting DMC

• 2 other identifiers: 25665-A (Full Trial)R01AI153376-01
• Study Type: interventional
• Target: 908
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea; Gastrointestinal Infection; Respiratory Viral Infection; Waterborne Diseases

Keywords

drinking water; private wells; UV disinfection

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 (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.

  12 months

Secondary Outcomes (1)

• Acute respiratory infection

  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 UV Device

Inactive UV Device

SHAM COMPARATOR

A household water treatment device with a lamp not emitting germicidal UV but still emitting light (appears identical to the active UV device).

Device: Inactive UV Device

Interventions

Active UV Device DEVICE

Active water treatment system

Active UV Device

Inactive UV Device DEVICE

Inactive water treatment system

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (1)

• Lee D, Denno D, Tarr P, Wu J, Stokdyk JP, Borchardt M, Murphy HM. Study design and methods of the Wells and Enteric disease Transmission (WET) Trial: a randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e068560. doi: 10.1136/bmjopen-2022-068560.

  PMID: 36863739 DERIVED

MeSH Terms

Conditions

Diarrhea; Waterborne Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Heather M Murphy, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, device installers, investigators, and outcomes assessor will all be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Research Professor

Model Details: A whole-home UV water treatment system will be installed and operated at a minimum of 50 millijoules per square centimeter.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 24, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)