Wells and Enteric Disease Transmission

RECRUITING

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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.

Conditions:

🦠 Diarrhea 🦠 Gastrointestinal Infection 🦠 Respiratory Viral Infection 🦠 Waterborne Diseases

🗓️ Study Start (Actual) 1 July 2021

🗓️ Primary Completion (Estimated) 31 May 2025

✅ Study Completion (Estimated) 31 May 2025

👥 Enrollment (Estimated) 908

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 6 Months to 59 Months (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 29 March 2021
First Submitted that Met QC Criteria 29 March 2021
First Posted 1 April 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 30 June 2023
Last Update Posted 5 July 2023
Last Verified June 2023