DiarrheaWETNCT04826991
Wells and Enteric Disease Transmission
A study testing Active UV Device and Inactive UV Device in people with Diarrhea and Gastrointestinal Infection, run by Temple University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Gastrointestinal Infection, Respiratory Viral Infection
- What is being tested?
- Active UV Device and Inactive UV Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 908 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 31 Aug 2027
- 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 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child resides in Adams, Berks, Bucks, Carbon, Chester, Columbia, Cumberland, Dauphin, Delaware, Lackawanna, Lancaster, Lebanon, Lehigh, Luzerne, Monroe, Montgomery, Montour, Northumberland, Northampton, Perry, Pike, Schuylkill, Wayne, Wyoming, and York county in Pennsylvania and all counties in New Jersey.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wells and Enteric Disease Transmission - A Randomized Trial of Children Supplied Drinking Water From Private Wells (WET-Trial)
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.
Read the detailed description
Investigators will conduct a triple-blinded randomized controlled trial of a whole-home UV water treatment device in southeastern Pennsylvania. Participating families will be randomized to receive an active UV device or a sham (inactive) UV device. Following the installation of the device, participants will be followed for one year. During that year, participants will respond to weekly text messages to report the presence of symptoms associated with gastrointestinal and respiratory illness in their children. Upon reporting symptoms, participants will complete an illness questionnaire on details regarding the illness and other potential exposure events. A subset of participants will submit groundwater samples as well as stool and saliva samples from their children. Water and stool samples will be analyzed for common waterborne pathogens. Saliva samples will be analyzed for immunoconversions to common waterborne pathogens (exploratory aim).
Under the guidance of an interdisciplinary advisory committee we will execute the following aims:
Aim 1- Quantify the incidence rate of endemic childhood GI associated with consuming untreated private well water and compare that to the incidence rate of consuming well water treated by UV.
Aim 1a- Construct a Quantitative Microbial Risk Assessment (QMRA) using water quality data we collect to estimate the risk of childhood GI associated with consuming untreated private well water and compare the incidence from the risk model to the incidence we calculate in Aim 1.
Aim 2- Identify, quantify and compare viral, bacterial and protozoan pathogens in stool of children consuming UV treated or untreated (sham) private well water (including both asymptomatic and symptomatic cases).
Aim 3- Explore the presence of pathogens in untreated well water and stool samples of children consuming untreated private well water (sham group only).
- Being tested
- Active UV Device, Inactive UV Device
- Keywords
- drinking water, private wells, UV disinfection
- Medical subject headings
- Diarrhea, Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active UV DeviceDevice
Active water treatment system
Inactive UV DeviceDevice
Inactive water treatment system
| Study group | Role | What they receive |
|---|---|---|
| Active UV Device | Active comparator | A household water treatment device with a lamp emitting germicidal UV. The device will be operated at 50 millijoule per square centimeter to treat >99.9% of all bacteria, protozoa, and most viruses in water supplies. Receives: Device: Active UV Device |
| Inactive UV Device | Sham comparator | A household water treatment device with a lamp not emitting germicidal UV but still emitting light (appears identical to the active UV device). Receives: Device: Inactive UV Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (type, incidence, severity, duration, etc.), 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.
Measured: 12 months
Secondary outcomes (1)
Acute respiratory infection
The investigators will collect data on the presence of acute respiratory infection symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (type, incidence, severity, duration, etc.) as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Acute respiratory infection is defined by the reporting of nasal congestion/discharge, sore throat or mouth sores, or cough lasting at least one day, in the absence of another explanation, such as isolated cough without nasal symptoms in known reactive airways disease. Each illness will be considered distinct when separated by ≥ 6 symptom-free days.
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 posted1 Apr 2021
- Study start1 Jul 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- A whole-home UV water treatment system will be installed and operated at a minimum of 50 millijoules per square centimeter.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 908 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Murphy, Temple University
- Investigators
- Heather M Murphy, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826991
- Sponsor's protocol ID
- 25665-A (Full Trial)
- Other IDs
- R01AI153376-01
- Acronym
- WET
- Status last verified
- Jun 2026
- First submitted
- 29 Mar 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee D, Denno D, Tarr P, Wu J, Stokdyk JP, Borchardt M, Murphy HM. Study design and methods of the Wells and Enteric disease Transmission (WET) Trial: a randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e068560. doi: 10.1136/bmjopen-2022-068560.
PubMed 36863739
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wells and Enteric Disease Transmission - A Randomized Trial of Children Supplied Drinking Water From Private Wells (WET-Trial)
- ClinicalTrials.gov ID
- NCT04826991
- Acronym / sponsor ID
- WET / 25665-A (Full Trial)
- Keywords
- drinking water, private wells, UV disinfection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 908 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Apr 2021 (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.
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.
Detailed description
Investigators will conduct a triple-blinded randomized controlled trial of a whole-home UV water treatment device in southeastern Pennsylvania. Participating families will be randomized to receive an active UV device or a sham (inactive) UV device. Following the installation of the device, participants will be followed for one year. During that year, participants will respond to weekly text messages to report the presence of symptoms associated with gastrointestinal and respiratory illness in their children. Upon reporting symptoms, participants will complete an illness questionnaire on details regarding the illness and other potential exposure events. A subset of participants will submit groundwater samples as well as stool and saliva samples from their children. Water and stool samples will be analyzed for common waterborne pathogens. Saliva samples will be analyzed for immunoconversions to common waterborne pathogens (exploratory aim).
Under the guidance of an interdisciplinary advisory committee we will execute the following aims:
Aim 1- Quantify the incidence rate of endemic childhood GI associated with consuming untreated private well water and compare that to the incidence rate of consuming well water treated by UV.
Aim 1a- Construct a Quantitative Microbial Risk Assessment (QMRA) using water quality data we collect to estimate the risk of childhood GI associated with consuming untreated private well water and compare the incidence from the risk model to the incidence we calculate in Aim 1.
Aim 2- Identify, quantify and compare viral, bacterial and protozoan pathogens in stool of children consuming UV treated or untreated (sham) private well water (including both asymptomatic and symptomatic cases).
Aim 3- Explore the presence of pathogens in untreated well water and stool samples of children consuming untreated private well water (sham group only).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A whole-home UV water treatment system will be installed and operated at a minimum of 50 millijoules per square centimeter.
| Arm | Type | Receives |
|---|---|---|
| Active UV Device | Active comparator | Device: Active UV DeviceA household water treatment device with a lamp emitting germicidal UV. The device will be operated at 50 millijoule per square centimeter to treat >99.9% of all bacteria, protozoa, and most viruses in water supplies. |
| Inactive UV Device | Sham comparator | Device: Inactive UV DeviceA household water treatment device with a lamp not emitting germicidal UV but still emitting light (appears identical to the active UV device). |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child resides in Adams, Berks, Bucks, Carbon, Chester, Columbia, Cumberland, Dauphin, Delaware, Lackawanna, Lancaster, Lebanon, Lehigh, Luzerne, Monroe, Montgomery, Montour, Northumberland, Northampton, Perry, Pike, Schuylkill, Wayne, Wyoming, and York county in Pennsylvania and all counties in New Jersey.
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Active UV DeviceActive water treatment system | Device | Active UV Device |
| Inactive UV DeviceInactive water treatment system | Device | Inactive UV Device |
Primary outcome
Incident gastrointestinal illness
Time frame: 12 months
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 (type, incidence, severity, duration, etc.), 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.
1 secondary outcome
Acute respiratory infection
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 16 Jun 2026.
- Derived from this study: PubMed 36863739Lee D, Denno D, Tarr P, Wu J, Stokdyk JP, Borchardt M, Murphy HM. Study design and methods of the Wells and Enteric disease Transmission (WET) Trial: a randomised controlled trial. BMJ Open. 2023 Mar 2;13(3):e068560. doi: 10.1136/bmjopen-2022-068560.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Heather M Murphy, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active UV Device and Inactive UV Device in people with Diarrhea and Gastrointestinal Infection, run by Temple University at 1 site in United States.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident gastrointestinal illness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04826991, which also lists 1 linked publication.
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 16 Jun 2026.