Gastrointestinal InfectionNCT04258059
Wells and Enteric Disease Transmission Trial (WET - Trial)
A study testing Active household UV water treatment device and Inactive household UV water treatment device in people with Gastrointestinal Infection and Respiratory Viral Infection, run by Temple University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Infection, Respiratory Viral Infection
- What is being tested?
- Active household UV water treatment device and Inactive household UV water treatment device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Household must rely on a private groundwater supply (private well or spring)
- 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.
- >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.
- 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.
Who cannot join
- 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.
- 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.
- Parents are unable to submit data through short message service (SMS) text messages (smartphone was not required).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)
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.
- Being tested
- Active household UV water treatment device, Inactive household UV water treatment device
- Keywords
- groundwater, private wells, acute gastrointestinal illness, respiratory infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active household UV water treatment deviceDevice
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 deviceDevice
This sham device will use a lamp not emitting germicidal UV.
| 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 household UV water treatment device |
| Inactive UV Device | Sham comparator | A device that appears identical to the active comparator device except the lamp will not emit germicidal UV. Receives: Device: Inactive household UV water treatment 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 (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.
Measured: 12 months
Secondary outcomes (1)
Acute respiratory illness (ARI)
As some waterborne pathogens (e.g., enterovirus and adenovirus) manifest with respiratory symptoms, we also captured ARI episodes, defined as: nasal congestion, nasal discharge, sore throat, mouth sores, or cough lasting at least one day, in the absence of another explanation such as isolated cough with a known history of asthma. Each incidence of respiratory infection was considered a unique illness event when preceded by ≥six 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 posted6 Feb 2020
- Study start30 Jun 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal InfectionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Principal investigator, Heather Murphy, Temple University
- Investigators
- Heather Murphy, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258059
- Sponsor's protocol ID
- 25665 (Pilot Trial)
- Status last verified
- Sep 2025
- First submitted
- 3 Feb 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hellard ME, Sinclair MI, Harris AH, Kirk M, Fairley CK. Cost of community gastroenteritis. J Gastroenterol Hepatol. 2003 Mar;18(3):322-8. doi: 10.1046/j.1440-1746.2003.02959.x.
PubMed 12603534Johnson 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.
PubMed 31412460Roberts 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. doi: 10.1017/s0950268802007690.
PubMed 12613740
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)
- ClinicalTrials.gov ID
- NCT04258059
- Acronym / sponsor ID
- 25665 (Pilot Trial)
- Keywords
- groundwater, private wells, acute gastrointestinal illness, respiratory infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 6 Feb 2020 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active UV Device | Active comparator | Device: Active household UV water treatment 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 household UV water treatment deviceA device that appears identical to the active comparator device except the lamp will not emit germicidal UV. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Household must rely on a private groundwater supply (private well or spring)
- 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.
- >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.
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
- Parents are unable to submit data through short message service (SMS) text messages (smartphone was not required).
- 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.
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 household UV water treatment deviceThis point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home. | Device | Active UV Device |
| Inactive household UV water treatment deviceThis sham device will use a lamp not emitting germicidal UV. | 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 (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.
1 secondary outcome
Acute respiratory illness (ARI)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 12603534Hellard ME, Sinclair MI, Harris AH, Kirk M, Fairley CK. Cost of community gastroenteritis. J Gastroenterol Hepatol. 2003 Mar;18(3):322-8. doi: 10.1046/j.1440-1746.2003.02959.x.
- Background: PubMed 31412460Johnson 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.
- Background: PubMed 12613740Roberts 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. doi: 10.1017/s0950268802007690.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Infection
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 4
Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric Anastomosis
Recurrent Ascending Cholangitis After Biliary-enteric Anastomosis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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 Murphy, PhD principal investigator
Assistant Professor
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 household UV water treatment device and Inactive household UV water treatment device in people with Gastrointestinal Infection and Respiratory Viral 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: finished, as of the sponsor's last update on 21 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT04258059, which also lists 3 linked publications.
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 21 Sep 2026.