Wells and Enteric Disease Transmission Trial (WET - Trial)

Respiratory Viral Infection Clinical Trial

Official title:

Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04258059
• Other study ID #: 25665 (Pilot Trial)
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: June 2023

Study information

• Verified date: July 2022
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: June 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Gastrointestinal Infection
• Infections
• Respiratory Viral Infection
• Virus Diseases

Intervention

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.
• Inactive household UV water treatment device
This sham device will use a lamp not emitting germicidal UV.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hellard ME, Sinclair MI, Harris AH, Kirk M, Fairley CK. Cost of community gastroenteritis. J Gastroenterol Hepatol. 2003 Mar;18(3):322-8. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months