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Wells and Enteric Disease Transmission Trial (WET - Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04258059
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Infection Respiratory Viral Infection Device: Active household UV water treatment device Device: Inactive household UV water treatment device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Active Comparator: Active UV Device
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
This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.

Sham Comparator: Inactive UV Device
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
This sham device will use a lamp not emitting germicidal UV.




Primary Outcome Measures :
  1. Incident gastrointestinal illness [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258059


Contacts
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Contact: Heather Murphy, PhD 215-204-4766 heather.murphy@temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Heather M Murphy, PhD    215-204-4766    heather.murphy@temple.edu   
Contact: Debbie Lee, PhD    215-204-5124    debbie.lee@temple.edu   
Principal Investigator: Heather M Murphy, PhD         
Sponsors and Collaborators
Temple University
Pennsylvania Department of Health
Investigators
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Principal Investigator: Heather Murphy, PhD Assistant Professor
Publications:
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04258059    
Other Study ID Numbers: 25665
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Temple University:
groundwater
private wells
acute gastrointestinal illness
respiratory infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases