DiarrheaRWELLNCT07818902
Rural Water Filtration and Health Study
A study testing Water filter in people with Diarrhea and Enteric Pathogens, run by Virginia Polytechnic Institute and State University.
Trial 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 more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Enteric Pathogens, Gastrointestinal Disease
- What is being tested?
- Water filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,584 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None (no exclusion criterion based on gender, race, ethnicity, language, or literacy)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Expanding Safe Water Access to Improve Health Outcomes in Appalachia: The Rural Water Filtration and Health (RWELL) Trial
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:
- Measure the effect of drinking water filtration on the incidence of reported acute gastrointestinal illness.
- Measure the effect of drinking water filtration on the presence and quantity of bacterial, protozoal, and viral pathogens detected in saliva and stool biospecimens.
- 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.
- Being tested
- Water filter
- 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
- Medical subject headings
- Diarrhea, Gastrointestinal Diseases, Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water filterDevice
Point-of-use multi-stage dispenser water filter with a membrane microfilter and a combined activated carbon and ion exchange filter
| Study group | Role | What they receive |
|---|---|---|
| Point-of-use water filter | Experimental | Households randomized to the treatment group will receive water filters at the beginning of the study. Receives: Device: Water filter |
| Control | No intervention | Households randomized to the control group will receive water filters after follow-up data collection is completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- East Tennessee State University, University of North Carolina, Chapel Hill, University of California, Berkeley, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Alasdair Cohen, Virginia Polytechnic Institute and State University
- Investigators
- Alasdair Cohen, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818902
- Sponsor's protocol ID
- 25-579
- Other IDs
- 1R01AI187428
- Acronym
- RWELL
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Safe Water Access to Improve Health Outcomes in Appalachia: The Rural Water Filtration and Health (RWELL) Trial
- ClinicalTrials.gov ID
- NCT07818902
- Acronym / sponsor ID
- RWELL / 25-579
- Keywords
- Acute Gastrointestinal Illness, Central Appalachia, Cluster Randomized Controlled Trial, Diarrhea, Drinking Water Contamination, Enteric Pathogens, Intervention Trial, Point-of-Use Water Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,584 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- East Tennessee State University, University of North Carolina, Chapel Hill, University of California, Berkeley, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Measure the effect of drinking water filtration on the incidence of reported acute gastrointestinal illness.
- Measure the effect of drinking water filtration on the presence and quantity of bacterial, protozoal, and viral pathogens detected in saliva and stool biospecimens.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-use water filter | Experimental | Device: Water filterHouseholds randomized to the treatment group will receive water filters at the beginning of the study. |
| Control | No intervention | –Households randomized to the control group will receive water filters after follow-up data collection is completed. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- None (no exclusion criterion based on gender, race, ethnicity, language, or literacy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water filterPoint-of-use multi-stage dispenser water filter with a membrane microfilter and a combined activated carbon and ion exchange filter | Device | Point-of-use water filter |
Primary outcome
Acute gastrointestinal illness incidence
Time frame: 12 months
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.
2 secondary outcomes
Waterborne pathogen infections
Time frame: 12 months
E. coli or pathogens in water samples
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alasdair Cohen, PhD principal investigator
Virginia Polytechnic Institute and State University
Questions about this trial
What is this clinical trial studying?
A study testing Water filter in people with Diarrhea and Enteric Pathogens, run by Virginia Polytechnic Institute and State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Lane Warmbrod, PhD (540-231-1816, wlane@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute gastrointestinal illness incidence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.