Wells and Enteric Disease Transmission

Diarrhea Clinical Trial

— WET  

Official title:

Wells and Enteric Disease Transmission - A Randomized Trial of Children Supplied Drinking Water From Private Wells (WET-Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826991
• Other study ID #: 25665-A (Full Trial)
• Secondary ID: R01AI153376-01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2023
• Source: Temple University
• Contact: Heather M Murphy, PhD
• Phone: (215)204-5124
• Email: heather.murphy[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Investigators will conduct a triple-blinded randomized controlled trial of a whole-home UV water treatment device in southeastern Pennsylvania. Participating families will be randomized to receive an active UV device or a sham (inactive) UV device. Following the installation of the device, participants will be followed for one year. During that year, participants will respond to weekly text messages to report the presence of symptoms associated with gastrointestinal and respiratory illness in their children. Upon reporting symptoms, participants will complete an illness questionnaire on details regarding the illness and other potential exposure events. A subset of participants will submit groundwater samples as well as stool and saliva samples from their children. Water and stool samples will be analyzed for common waterborne pathogens. Saliva samples will be analyzed for immunoconversions to common waterborne pathogens (exploratory aim). Under the guidance of an interdisciplinary advisory committee we will execute the following aims: Aim 1- Quantify the incidence rate of endemic childhood GI associated with consuming untreated private well water and compare that to the incidence rate of consuming well water treated by UV. Aim 1a- Construct a Quantitative Microbial Risk Assessment (QMRA) using water quality data we collect to estimate the risk of childhood GI associated with consuming untreated private well water and compare the incidence from the risk model to the incidence we calculate in Aim 1. Aim 2- Identify, quantify and compare viral, bacterial and protozoan pathogens in stool of children consuming UV treated or untreated (sham) private well water (including both asymptomatic and symptomatic cases). Aim 3- Explore the presence of pathogens in untreated well water and stool samples of children consuming untreated private well water (sham group only).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 908
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Child resides in Berks, Bucks, Carbon, Chester, Dauphin, Delaware, Lancaster, Lebanon, Lehigh, Northampton, Montgomery, Monroe, Pike and Schuylkill 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
• 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 for microbiological contamination before consumption
• Child exclusively drinks bottled water

Related Conditions & MeSH terms

• Communicable Diseases
• Diarrhea
• Gastrointestinal Infection
• Infections
• Respiratory Viral Infection
• Virus Diseases
• Waterborne Diseases

Intervention

Device:
• Active UV Device
Active water treatment system
• Inactive UV Device
Inactive water treatment system

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute respiratory infection	The investigators will collect data on the presence of acute respiratory infection 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. Acute respiratory infection is defined by the reporting of nasal congestion/discharge, sore throat or mouth sores, or cough lasting at least one day, in the absence of another explanation, such as isolated cough without nasal symptoms in known reactive airways disease. Each illness will be considered distinct when separated by = 6 symptom-free days.	12 months