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The Research of Novel Electrolyzed Water Spray to Eradicate Bacteria E-coli and an Attenuated Human Flu Virus

Primary Purpose

Bacterial Growth, Novel Influenza A (H1N1)

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands
Sponsored by
Dove Medical Press Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Growth focused on measuring Electrolyzed water device, Hydroxyl radical, Tap water, Spray, E-coli, Human flu virus

Eligibility Criteria

24 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18-60 years. Male or female of any race and ethnicity. Subject agrees to comply with study requirements. Exclusion Criteria: 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

Sites / Locations

  • Huinuode Biotechnology Co., Ltd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

electrolyzed water spray group

untreated tap water group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
July 29, 2023
Sponsor
Dove Medical Press Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05797103
Brief Title
The Research of Novel Electrolyzed Water Spray to Eradicate Bacteria E-coli and an Attenuated Human Flu Virus
Official Title
A Novel Electrolyzed Water Spray Reduces the Number of Bacteria E-coli and an Attenuated Human Flu Virus on Human Hands
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2023 (Actual)
Primary Completion Date
July 2, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dove Medical Press Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Growth, Novel Influenza A (H1N1)
Keywords
Electrolyzed water device, Hydroxyl radical, Tap water, Spray, E-coli, Human flu virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
This is an open label, two arm clinical study
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrolyzed water spray group
Arm Type
Experimental
Arm Description
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.
Arm Title
untreated tap water group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
A novel electrolyzed water spray reduces numbers of bacteria E-coli and an attenuated human flu virus on human hands
Intervention Description
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.
Primary Outcome Measure Information:
Title
Flush and eradicate the number of bacteria E-coli on human hands.
Description
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.
Time Frame
10 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-60 years. Male or female of any race and ethnicity. Subject agrees to comply with study requirements. Exclusion Criteria: 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
Facility Information:
Facility Name
Huinuode Biotechnology Co., Ltd.
City
Qingdao
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Research of Novel Electrolyzed Water Spray to Eradicate Bacteria E-coli and an Attenuated Human Flu Virus

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