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RecruitingNCT07818902RWELLUpdated Nov 9, 2026

Rural Water Filtration and Health Study

An interventional study of Water filter in Diarrhea, Enteric Pathogens and Gastrointestinal Disease, sponsored by Virginia Polytechnic Institute and State University. Recruiting at 2 sites in United States. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention

Updated Nov 9, 2026Now RecruitingFirst site in United States+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,584
Allocation
Randomized
Ages
6 Months and older
Sex
All
01

Study summary

The goal of this intervention trial is to learn if the use of drinking water filters will result in improved health outcomes for people living in homes with well water and spring water in rural regions of Central Appalachia.

Read the detailed description

Consumption of unsafe drinking water is associated with a substantial burden of disease. Tens of millions of people in the United States live in homes with unregulated private wells, primarily in rural regions. However, our understanding of drinking water contaminants and associated health impacts for individuals living in households with private water supply in rural areas of the United States is severely limited by a lack of data - particularly for individuals living in low-income households in rural areas of Appalachia, and in the Central Appalachia region especially.

The overarching goal of this study is to assess the potential of a household-level water treatment intervention for expanding safe water access and improving health outcomes and wellbeing for rural households without utility-supplied water. Investigators will enroll approximately 480 households (approximately 1,600 individuals) that use well water and spring water and conduct a cluster-randomized controlled trial in southwest Virginia and northeast Tennessee to evaluate the hypothesized benefits of point-of-use water filtration.

Investigators will undertake the following aims:

  1. Measure the effect of drinking water filtration on the incidence of reported acute gastrointestinal illness.
  2. Measure the effect of drinking water filtration on the presence and quantity of bacterial, protozoal, and viral pathogens detected in saliva and stool biospecimens.
  3. Quantify fecal indicator organisms, waterborne pathogens, and regulated chemical contaminants in drinking water samples.

This study was designed to rigorously assess the hypothesized benefits of a relatively low-cost and easy to use point-of-use water treatment approach that can also improve the taste of water, and is a less-costly alternative to bottled water. Findings from this study will also substantially improve our understanding of which waterborne and enteric pathogens infants, children, and adults living in households with private water supplies in rural areas of Central Appalachia are exposed to and infected with, enabling more informed estimates of the associated burden of disease for rural populations without utility-supplied water.

02

Conditions studied

  • Diarrhea
  • Enteric Pathogens
  • Gastrointestinal Disease
  • Waterborne Diseases

Keywords

  • Acute Gastrointestinal Illness
  • Central Appalachia
  • Cluster Randomized Controlled Trial
  • Diarrhea
  • Drinking Water Contamination
  • Enteric Pathogens
  • Intervention Trial
  • Point-of-Use Water Treatment
  • Rural Health
  • Spring Water
  • Water Filtration
  • Waterborne Diseases
  • Well Water
03

In context

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

This study's planned enrollment of 1,584 is above the median of 137 across 738 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 127 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Home is located in a study county in southwest Virginia or northeast Tennessee
  • There is at least one adult (aged 18 or older) who regularly (>6 months per year) resides in the household
  • Household does not have utility-supplied water (and \<33% of household members regularly drink bottled water)
  • Reported household income is \<80% of the county median income (based on US Department of Housing and Urban Development thresholds by household population)

Exclusion criteria

Exclusion Criteria:

  • None (no exclusion criterion based on gender, race, ethnicity, language, or literacy)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,584 participants (estimated)

Study arms

  • Experimental
    Point-of-use water filter

    Households randomized to the treatment group will receive water filters at the beginning of the study.

    Device: Water filter

  • No intervention
    Control

    Households randomized to the control group will receive water filters after follow-up data collection is completed.

Interventions

  • DeviceWater filter

    Point-of-use multi-stage dispenser water filter with a membrane microfilter and a combined activated carbon and ion exchange filter

06

What researchers measure

Primary outcomes

  1. Acute gastrointestinal illness incidence

    Incidence of household-level acute gastrointestinal illness (AGI), based on individual-level reported 7-day AGI. AGI case definition: reported diarrhea today and/or any day in the last seven days. Individual-level reported fever, nausea, cramps, and vomiting data will also be collected. For those with reported AGI, investigators will also ask if they had three or more loose stools in a 24-hour period.

    Time frame: 12 months

Secondary outcomes

  1. Waterborne pathogen infections

    Detection of one or more pathogens that are either exclusively waterborne or highly likely to be waterborne via analysis of saliva and stool samples for bacterial, protozoal, and viral targets.

    Time frame: 12 months

  2. E. coli or pathogens in water samples

    Detection of E. coli in collected well and spring water samples or detection of enteric pathogens in filtered well and spring water samples.

    Time frame: 12 months

07

Study locations

1 of 2 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
2 sites added — first site in United States
Show 2 added (2 United States)
  • East Tennessee State University · Johnson City, United States
  • Virginia Tech · Blacksburg, United States
Nov 9, 2026
Start date
Sep 2026→Nov 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    2 sites added — first site in United States
    Show 2 added (2 United States)
    • East Tennessee State University · Johnson City, United States
    • Virginia Tech · Blacksburg, United States
    Start date Sep 2026→Nov 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07818902
Responsible party
Alasdair Cohen (Associate Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Sep 14, 2026
Start date
Nov 2026 (estimated)
Primary completion
Mar 2030 (estimated)
Completion
May 2030 (estimated)
Last update
Nov 9, 2026

Study contacts

Kelsey Lane Warmbrod, PhD
Contact
wlane@vt.edu
540-231-1816
Bethesda O'Connell, DrPH
Contact
oconnell@etsu.edu
423-439-4816
Alasdair Cohen, PhD
principal investigator · Virginia Polytechnic Institute and State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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