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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the UV water treatment for gastroenteritis in children?

Research shows that UV light devices can effectively inactivate viruses and bacteria in water, achieving significant reductions in harmful microorganisms. This suggests that UV water treatment could be effective in reducing pathogens that cause gastroenteritis in children. ^{1 2 3 4 5}

Is UV water treatment safe for humans?

Research on UV water treatment devices shows they are effective in killing harmful microorganisms in water, and no safety concerns for humans have been reported in these studies. ^{1 2 3 6 7}

How does the UV Water Treatment for Gastroenteritis in Children differ from other treatments?

The UV Water Treatment is unique because it uses ultraviolet light to disinfect water, effectively inactivating viruses and bacteria without the use of chemicals, making it a safe and environmentally friendly option compared to traditional chemical treatments. ^{1 2 3 8 9}

Research Team

Heather M Murphy, PhD

Principal Investigator

Temple University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of a portable handheld UV light device for the disinfection of viruses and bacteria in water. [2021]

2. Netherlands 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Cryptosporidium inactivation by low-pressure UV in a water disinfection device. [2003]

4. England pubmed.ncbi.nlm.nih.gov

New water disinfection system using UVA light-emitting diodes. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Drinking water treatment with ultraviolet light for travelers -- Evaluation of a mobile lightweight system. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Field evaluation of a novel UV water disinfection system for use in underserved rural communities. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of adaptive low cost solar water pasteurization device for providing safe potable water in rural households. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Development of a new water sterilization device with a 365 nm UV-LED. [2021]

9. England 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. [2022]