Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diarrhea
  • Gastrointestinal Infection
  • Respiratory Viral Infection
  • Waterborne Diseases
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A whole-home UV water treatment system will be installed and operated at a minimum of 50 millijoules per square centimeter.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Participants, device installers, investigators, and outcomes assessor will all be blinded.Primary Purpose: Prevention

Participation Requirements

Age
Younger than 659 years
Gender
Both males and females

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, participa...

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).

Tracking Information

NCT #
NCT04826991
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Heather M Murphy, PhD Temple University