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Completed NCT04258059

Wells and Enteric Disease Transmission Trial (WET - Trial)

Conditions: Gastrointestinal Infection, Respiratory Viral Infection

Sex: All
Ages: 6 Months – 59 Months
Healthy volunteers: Yes
Phase: NA
Enrollment: 28
Sponsor: Temple University

Location: Temple University Philadelphia Pennsylvania

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.

Eligibility Criteria

Inclusion Criteria: 1. Household must rely on a private groundwater supply (private well or spring) 2. Child must be over six months and under 4 years old at enrollment so that they will be under five years of age for the duration of the 12-month study period. 3. \>75% of the water the child consumes must be tap water untreated by any treatment device capable of microbial water treatment. Proportion is estimated by the parent and includes water used to make juice or formula. 4. Child must be a full-time resident of the home, defined as living in the home for five or more days every week. The intervention is administered at the household level; therefore the child must reside at home and be regularly exposed to the intervention. Exclusion Criteria: 1. Child has a chronic, gastrointestinal condition (e.g., Crohn's disease), which may complicate differentiation between signs and symptoms of gastrointestinal illness associated with drinking water and those of the pre-existing condition. 2. Child is immunocompromised, which may result in increased susceptibility to waterborne illness. Daily oral steroids also considered an exclusion criteria due to their associated immunosuppressive effects. 3. Parents are unable to submit data through short message service (SMS) text messages (smartphone was not required). 4. Household treats their water for microbiological contamination at point-of-entry or point-of-use. In the case where multiple children met the eligibility criteria, the youngest eligible child was enrolled. Records were maintained on the recruitment process documenting reasons for eligibility and those that declined to participate in the study.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04258059). StuddyBuddy aggregates publicly available trial information.