Wells and Enteric Disease Transmission Trial (WET

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Infection Respiratory Viral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Active household UV water treatment device

Intervention Type DEVICE

This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.

Inactive UV Device

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

Group Type SHAM_COMPARATOR

Inactive household UV water treatment device

Intervention Type DEVICE

This sham device will use a lamp not emitting germicidal UV.

Interventions

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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.

Intervention Type DEVICE

Inactive household UV water treatment device

This sham device will use a lamp not emitting germicidal UV.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes