Bacterial GrowthNCT05797103
The Research of Novel Electrolyzed Water Spray to Eradicate Bacteria E-coli and an Attenuated Human Flu Virus
A study testing A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands in people with Bacterial Growth and Novel Influenza A (H1N1), run by Dove Medical Press Ltd at 1 site in China.
Trial summary
The purpose of this study is to test whether spraying the hand of patients by use of the novel electrolyzed water spray will decrease the number of bacteria E-coli and the virus titer of an attenuated human flu virus. Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Growth, Novel Influenza A (H1N1)
- What is being tested?
- A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2023to 27 Jul 2023
- 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 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years.
- Male or female of any race and ethnicity.
- Subject agrees to comply with study requirements.
Who cannot join
- Severely unhealthy participants.
- 80 years or older.
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels.
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
- Immunocompromised subjects, or with a history of active or malignant disease as determined by the participant's medical history.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Electrolyzed Water Spray Reduces the Number of Bacteria E-coli and an Attenuated Human Flu Virus on Human Hands
The purpose of this study is to test whether spraying the hand of patients by use of the novel electrolyzed water spray will decrease the number of bacteria E-coli and the virus titer of an attenuated human flu virus.
Read the detailed description
In this study, water including tap water, pure water and salt water, and an apparatus for producing electrolyzed water were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential（ORP）≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of dissolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion. The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U).
In this study, we hypothesize that the instantly generated electrolyzed water mist spray or spray relieves skin and mucosal inflammation including the itches through indirect actions by killing microbials and reducing endotoxin level and direct action by serving as an inflammatory inhibitor.
Detection of residual E. coli in the collected water samples. 1 ml of the collected water sample is inoculated on the surface of the solid LB agar plates and cultured overnight at 37°C in an incubator. Calculate the total number of bacterial colonies as CFU. In other words, the total number of bacteria/ml inoculated water sample (CFU) is the number of colonies formed on the surface of the plate. It is assumed that the bacteria on the hands are mostly washed out into the drain water sample pool and that the left over bacteria on the hand after rinsing is negligible. The leftover also can be measured by pressing the rinsed hand after on a large LB agar plate and then count the colonies (unstained and stained) after overnight incubation at 37°C.
Detection of residual human influenza virus H1N1 titers in the collected water samples. Viral titer (TCID50) is used to measure the infection of the dosage of 50% MDCK cells. MDCK cells were inoculated into 96-well plates at 1.0×104 cells per well and cultured overnight at 37°C in a cell culture incubator. We wash the hands and collect the drained water for the titer measurement. 100 ul of the water sample after the multiple proportion dilutions is inoculated into 96-well plates which contain overnight cultured MDCK cells. After 3 days of incubation at 37°C, TCID50 was calculated using the Reed and Muench method. 1 plaque forming unit (PFU) is equal to 1 alive virus particle.
- Conditions
- Bacterial Growth, Novel Influenza A (H1N1)
- Being tested
- A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands
- Keywords
- Electrolyzed water device, Hydroxyl radical, Tap water, Spray, E-coli, Human flu virus
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human handsDevice
Electrolyzed water spray group will use the novel electrolyzed water spray to flush the hands that daub E. coli and attenuated human influenza virus H1N1 for 6 seconds per hand, and then use 4 seconds to collect a sample of the water flowing from the sprayed hand and apply it to the plate. Untreated tap water group will use the untreated tap water spray to flush the hands that daub E. coli and attenuated human influenza virus H1N1 for 6 seconds per hand, and then use 4 seconds to collect a sample of the water flowing from the sprayed hand and apply it to the plate.
| Study group | Role | What they receive |
|---|---|---|
| electrolyzed water spray group | Experimental | Participants with bacteria E-coli and an attenuated human flu virus on their hands will receive one treatment with the novel electrolyzed water and complete the questionnaire. Receives: Device: A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands |
| untreated tap water group | Experimental | Participants with bacteria E-coli and an attenuated human flu virus on their hands will receive one treatment with the untreated tap water and complete the questionnaire. Receives: Device: A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flush and eradicate the number of bacteria E-coli on human hands.
Calculate the total number of bacterial colonies formed, expressed as CFU, and the total number of bacterial colonies (CFU) is the total number of colonies formed on the surface of a solid medium in 1 ml of a water sample.
Viral titer (TCID50) indicates the minimum number of bacteria or amount of toxin required to infect half of an animal of a certain body weight or age by a specified route of infection within a specified time.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start29 Jan 2023
- Primary completion2 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial GrowthStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dove Medical Press Ltd
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797103
- Sponsor's protocol ID
- jia19961018
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Electrolyzed Water Spray Reduces the Number of Bacteria E-coli and an Attenuated Human Flu Virus on Human Hands
- ClinicalTrials.gov ID
- NCT05797103
- Acronym / sponsor ID
- jia19961018
- Conditions
- Bacterial Growth, Novel Influenza A (H1N1)
- Keywords
- Electrolyzed water device, Hydroxyl radical, Tap water, Spray, E-coli, Human flu virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dove Medical Press LtdResearch network
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 4 Apr 2023 (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 purpose of this study is to test whether spraying the hand of patients by use of the novel electrolyzed water spray will decrease the number of bacteria E-coli and the virus titer of an attenuated human flu virus.
Detailed description
In this study, water including tap water, pure water and salt water, and an apparatus for producing electrolyzed water were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential（ORP）≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of dissolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion. The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U).
In this study, we hypothesize that the instantly generated electrolyzed water mist spray or spray relieves skin and mucosal inflammation including the itches through indirect actions by killing microbials and reducing endotoxin level and direct action by serving as an inflammatory inhibitor.
Detection of residual E. coli in the collected water samples. 1 ml of the collected water sample is inoculated on the surface of the solid LB agar plates and cultured overnight at 37°C in an incubator. Calculate the total number of bacterial colonies as CFU. In other words, the total number of bacteria/ml inoculated water sample (CFU) is the number of colonies formed on the surface of the plate. It is assumed that the bacteria on the hands are mostly washed out into the drain water sample pool and that the left over bacteria on the hand after rinsing is negligible. The leftover also can be measured by pressing the rinsed hand after on a large LB agar plate and then count the colonies (unstained and stained) after overnight incubation at 37°C.
Detection of residual human influenza virus H1N1 titers in the collected water samples. Viral titer (TCID50) is used to measure the infection of the dosage of 50% MDCK cells. MDCK cells were inoculated into 96-well plates at 1.0×104 cells per well and cultured overnight at 37°C in a cell culture incubator. We wash the hands and collect the drained water for the titer measurement. 100 ul of the water sample after the multiple proportion dilutions is inoculated into 96-well plates which contain overnight cultured MDCK cells. After 3 days of incubation at 37°C, TCID50 was calculated using the Reed and Muench method. 1 plaque forming unit (PFU) is equal to 1 alive virus particle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrolyzed water spray group | Experimental | Device: A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human handsParticipants with bacteria E-coli and an attenuated human flu virus on their hands will receive one treatment with the novel electrolyzed water and complete the questionnaire. |
| untreated tap water group | Experimental | Device: A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human handsParticipants with bacteria E-coli and an attenuated human flu virus on their hands will receive one treatment with the untreated tap water and complete the questionnaire. |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years.
- Male or female of any race and ethnicity.
- Subject agrees to comply with study requirements.
Key exclusion criteria (8 listed)
- Severely unhealthy participants.
- 80 years or older.
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study.
- Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels.
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
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 |
|---|---|---|
| A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human handsElectrolyzed water spray group will use the novel electrolyzed water spray to flush the hands that daub E. coli and attenuated human influenza virus H1N1 for 6 seconds per hand, and then use 4 seconds to collect a sample of the water flowing from the sprayed hand and apply it to the plate. Untreated tap water group will use the untreated tap water spray to flush the hands that daub E. coli and attenuated human influenza virus H1N1 for 6 seconds per hand, and then use 4 seconds to collect a sample of the water flowing from the sprayed hand and apply it to the plate. | Device | electrolyzed water spray group, untreated tap water group |
Primary outcome
Flush and eradicate the number of bacteria E-coli on human hands.
Time frame: 10 seconds
Calculate the total number of bacterial colonies formed, expressed as CFU, and the total number of bacterial colonies (CFU) is the total number of colonies formed on the surface of a solid medium in 1 ml of a water sample. Viral titer (TCID50) indicates the minimum number of bacteria or amount of toxin required to infect half of an animal of a certain body weight or age by a specified route of infection within a specified time.
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 1 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands in people with Bacterial Growth and Novel Influenza A (H1N1), run by Dove Medical Press Ltd at 1 site in China.
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 3 inclusion and 8 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 1 Aug 2023. 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 China. 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. 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?
Flush and eradicate the number of bacteria E-coli on human hands. (time frame: 10 seconds). 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 1 Aug 2023.