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Wells and Enteric Disease Transmission Trial (WET - Trial)

Primary Purpose

Gastrointestinal Infection, Respiratory Viral Infection

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active household UV water treatment device
Inactive household UV water treatment device
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Infection focused on measuring groundwater, private wells, acute gastrointestinal illness, respiratory infection

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active UV Device

Inactive UV Device

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2020
Last Updated
July 29, 2022
Sponsor
Temple University
Collaborators
Pennsylvania Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04258059
Brief Title
Wells and Enteric Disease Transmission Trial (WET - Trial)
Official Title
Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Temple University
Collaborators
Pennsylvania Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Infection, Respiratory Viral Infection
Keywords
groundwater, private wells, acute gastrointestinal illness, respiratory infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active UV Device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Inactive UV Device
Arm Type
Sham Comparator
Arm Description
A device that appears identical to the active comparator device except the lamp will not emit germicidal UV.
Intervention Type
Device
Intervention Name(s)
Active household UV water treatment device
Intervention Description
This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.
Intervention Type
Device
Intervention Name(s)
Inactive household UV water treatment device
Intervention Description
This sham device will use a lamp not emitting germicidal UV.
Primary Outcome Measure Information:
Title
Incident gastrointestinal illness
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Murphy, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12603534
Citation
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.
Results Reference
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PubMed Identifier
31412460
Citation
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.
Results Reference
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PubMed Identifier
12613740
Citation
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.
Results Reference
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Wells and Enteric Disease Transmission Trial (WET - Trial)

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