UV Water Treatment for Gastroenteritis in Children

(WET Trial)

Overseen By Heather M Murphy, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Must not be taking: Oral steroids

Disqualifiers: Immunocompromised, Chronic GI condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

908 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an ultraviolet (UV) light device can reduce stomach illnesses in young children by treating private well water. The study compares families using a special UV water treatment (Active UV Device) to those using a look-alike device that doesn’t clean the water (Inactive UV Device). It also examines germs in the children's stool and their home’s well water to better understand water-related illnesses. Families in Pennsylvania and New Jersey with children under 5 who drink untreated well water might be suitable for this trial. As an unphased study, this trial offers families the chance to contribute to important research that could enhance water safety for young children.

Will I have to stop taking my current medications?

The trial does not specify if participants need to stop taking their current medications. However, children taking daily oral steroids are excluded from participating.

What prior data suggests that this UV water treatment is safe for children?

Research has shown that using ultraviolet (UV) light to clean water is generally safe. Studies have found that UV light, especially in the UVC range, effectively kills bacteria, viruses, and other germs without leaving harmful residues. This makes it a safer option compared to chemical disinfectants, which might leave behind unwanted substances.

Past research demonstrated that UV devices can stop the spread of viruses like norovirus, which often spreads through contaminated water, food, and surfaces. Using UV light to disinfect water is well-tolerated, with no major side effects reported in the available studies.

While researchers are still studying the specific use of an Active UV Device for its effects on stomach illnesses in children, current evidence supports its safety for cleaning water. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for gastroenteritis in children, which often include rehydration solutions and medications to manage symptoms, the active UV device offers a unique approach by directly targeting pathogens in water. This device uses germicidal UV light to eliminate over 99.9% of bacteria, protozoa, and most viruses in contaminated water, providing a potential preventive strategy rather than just treating symptoms. Researchers are excited about this innovation because it could offer a non-invasive, chemical-free method to reduce the incidence of gastroenteritis, particularly in areas where access to clean water is a challenge.

What evidence suggests that the UV water treatment is effective for gastroenteritis in children?

Research has shown that ultraviolet (UV) light effectively reduces harmful germs in water. Studies have found that UVC light, a type of UV light, can kill over 99.9% of bacteria, protozoa, and many viruses in water. UVC light damages the germs' DNA, preventing them from multiplying and causing illness. One study highlighted that UVC LED treatment can quickly remove viruses from water, making it a promising method for cleaner water. In this trial, participants will use either an Active UV Device, which emits germicidal UV light, or an Inactive UV Device, which does not emit germicidal UV light, to treat private well water. The trial aims to evaluate whether using a UV device can help reduce stomach illnesses (gastroenteritis) in children. ^{1 2 6 7 8}

Who Is on the Research Team?

Heather M Murphy, PhD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

This trial is for children under 5 years old who drink untreated well water and live in specific counties of Pennsylvania. They must be full-time residents at a home served by a private well, and their parent or guardian needs to have texting capabilities on their phone. Children who only drink bottled water, are immunocompromised, have chronic GI conditions, or take daily oral steroids cannot participate.

Inclusion Criteria

Your home gets its water from a private well.

Child resides in Berks, Bucks, Chester, Lancaster, Lehigh, or Montgomery County in Pennsylvania

My child is under 4 and drinks untreated well water at home.

Exclusion Criteria

My child has a long-term stomach or intestine condition.

My child is on daily oral steroids.

You treat your household water to remove bacteria before drinking it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an active UV device or a sham UV device for water treatment

12 months

Weekly virtual check-ins via text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active UV Device
• Inactive UV Device

Trial Overview The study aims to see if treating private well water with ultraviolet light (UV) can reduce gastrointestinal illnesses in young children compared to using an inactive UV device. It's the first randomized controlled trial focused on illness from drinking untreated well water.

How Is the Trial Designed?

Group I: Active UV Device Active Control 1 Intervention

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.

Group II: Inactive UV Device Placebo Group 1 Intervention

A household water treatment device with a lamp not emitting germicidal UV but still emitting light (appears identical to the active UV device).

Active UV Device is already approved in United States, European Union, Canada for the following indications:

Approved in United States as UV Water Treatment Device for:

• Disinfection of private well water to reduce gastrointestinal illnesses

Approved in European Union as Ultraviolet Light Disinfection Device for:

• Water treatment for drinking water systems
• Reduction of microbiological contaminants in water

Approved in Canada as UV Water Purifier for:

• Disinfection of drinking water
• Reduction of bacteria, viruses, and protozoa in water

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

A handheld UV light device effectively inactivated at least 4 log₁₀ of poliovirus type 1, rotavirus SA-11, and MS-2 virus in 500 mL of water, meeting safety standards for virus reduction set by health organizations.

However, in water with high turbidity and organic matter, additional filtration was required to achieve the same level of virus reduction, indicating that water clarity is important for the device's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a portable handheld UV light device for the disinfection of viruses and bacteria in water. Abd-Elmaksoud, S., Naranjo, JE., Gerba, CP.[2021]

UV-LEDs, particularly those with wavelengths of 284 and 289 nm, have been shown to effectively inactivate Cryptosporidium parvum oocysts in water, providing a safer alternative to traditional UV lamps that use mercury.

The study utilized an in vivo quantitative inactivation assay with immunodeficient mice to compare the effectiveness of UV-LEDs against a UV lamp, revealing that UV-LEDs can delay the shedding of oocysts, indicating their potential for water treatment applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ultraviolet light-emitting diodes (UV-LED) at four different peak wavelengths against Cryptosporidium parvum oocysts by inactivation assay using immunodeficient mice. Takahashi, K., Matsubayashi, M., Ohashi, Y., et al.[2020]

A new disinfection device using high-energy UVA-LED effectively inactivated various bacteria in water, achieving over 5-log(10) reductions in bacteria like Vibrio parahaemolyticus and Staphylococcus aureus within 75 minutes.

The study revealed that the disinfection mechanism involves the formation of reactive species like hydroxyl radicals and hydrogen peroxide, which are crucial for the effectiveness of UVA irradiation in killing bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New water disinfection system using UVA light-emitting diodes. Hamamoto, A., Mori, M., Takahashi, A., et al.[2013]

The UV Waterworks device effectively inactivated Cryptosporidium parvum oocysts, as demonstrated by a study involving 60 neonatal mice, where none showed signs of infection after exposure to treated water.

The device delivered a UV dose of approximately 120 mJ/cm2, resulting in a reduction of oocyst infectivity by at least 5.4 orders of magnitude, compared to a control group that showed 95% infection with untreated water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryptosporidium inactivation by low-pressure UV in a water disinfection device. Drescher, AC., Greene, DM., Gadgil, AJ.[2003]

A novel UV water disinfection system demonstrated a high level of effectiveness, achieving a 7.12 log10 reduction of the bacteriophage MS-2 in laboratory tests and maintaining over 5 log10 E. coli removal in water with turbidity levels up to 18 NTU.

Field testing in a Native American reservation showed that the solar-powered system successfully treated groundwater with fecal contamination, exceeding drinking water disinfection standards, making it a reliable and cost-effective solution for underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field evaluation of a novel UV water disinfection system for use in underserved rural communities. Younis, BA., Mahoney, LE., Yao, S.[2023]

A simplified, low-cost pasteurization device effectively inactivates diarrheal pathogens in water from natural sources, achieving a significant reduction of Escherichia coli by 6.8 log CFU/ml when exposed to sunlight for about 30 minutes.

The treated water meets most potable water quality standards and can be stored for up to 6 months at room temperature without losing quality, making this device a practical solution for providing safe drinking water in rural, low-resource areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of adaptive low cost solar water pasteurization device for providing safe potable water in rural households. Zaman, S., Yousuf, A., Begum, A., et al.[2020]

The SteriPEN(®) effectively reduces bacteria in water by over 99.99% when used correctly, but without water agitation, the reduction drops to about 95%.

The device operates at an optimal UV-C wavelength of 254 nm for inactivating microorganisms, but user safety is a concern due to potential errors in application, highlighting the need for proper education on its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drinking water treatment with ultraviolet light for travelers -- Evaluation of a mobile lightweight system. Timmermann, LF., Ritter, K., Hillebrandt, D., et al.[2019]

A new sterilization system using a UVA-LED emitting light at 365 nm effectively inactivated various bacteria, including E. coli and Salmonella, demonstrating its potential as a disinfection method.

Unlike traditional mercury lamps, the UVA-LED is safer and more compact, making it a promising alternative for water sterilization without the hazards associated with mercury disposal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a new water sterilization device with a 365 nm UV-LED. Mori, M., Hamamoto, A., Takahashi, A., et al.[2021]

The study demonstrated that UV-A light emitting diodes (LEDs) can effectively inactivate Legionella pneumophila and Legionella dumoffii in water, achieving 99.9% and 99.1% inactivation, respectively, at a UV-A dose of 1700 mJ/cm2.

This UV-A LED system is shown to be more economical and efficient than traditional UV-C and UV-B methods, suggesting it could be a viable option for installation in water purification systems to enhance public health safety against Legionnaires' disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sequential utilization of the UV-A (365 nm) fluence rate for disinfection of water, contaminated with Legionella pneumophila and Legionelladumoffii. Allahyari, E., Carraturo, F., De Risi, A., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-communicable-diseases-4-2021-0f93e

UV Water Treatment for Gastroenteritis in Children 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 ...

2. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.885413/full

Effect of Ultraviolet-C Light-Emitting Diode Treatment on ... Our study highlights the benefits of UVC LED treatment in successfully eliminating waterborne viruses in a prompt, resistance-reducing, and energy-efficient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9082547/

Evaluation of Virucidal Efficacy of Human Norovirus Using ... In addition to preventing mercury disposal, UVC-LED irradiation has numerous advantages, including lesser warmup time, better device operation, ...

4. mdpi.com mdpi.com/2076-0817/11/2/226

A Perspective on Disinfection of Water and Surfaces Using ... Ultraviolet Subtype C (UVC) light-emitting diodes (LEDs) can disrupt the norovirus transmission chain for water, food, and surfaces. Here, we illuminate ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5824029/

Portable Ultraviolet Light Surface-Disinfecting Devices for ... This health technology assessment evaluated the effectiveness and budget impact of portable ultraviolet (UV) light surface-disinfecting devices for reducing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8879714/

Illuminating Human Norovirus: A Perspective on ... Ultraviolet Subtype C (UVC) light-emitting diodes (LEDs) can disrupt the norovirus transmission chain for water, food, and surfaces.

7. cdc.gov cdc.gov/infection-control/media/pdfs/Guideline-Norovirus-H.pdf

Guideline for the Prevention and Control of Norovirus ... methods for environmental disinfection, such as ozone mist from a humidifying device, fumigation, UV irradiation, and fogging. This search ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1572100021001605

Pilot study on the decontamination efficacy of an installed ... Conclusions. The automated 222-nm UVC disinfection device with a motion sensor significantly reduced AB surface contamination of a shared bathroom.