Bacterial OvergrowthEarly Phase 1NCT04495920
Clinical Evaluation of the Residual Antimicrobial Activity
A Early Phase 1 study testing CGB-S-100 in people with Bacterial Overgrowth, run by CAGE Bio Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the residual antimicrobial efficacy of one test product as defined by the difference between the number of a challenge bacterial species recovered following exposure to the test product and the number recovered when untreated (negative control). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Overgrowth
- What is being tested?
- CGB-S-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 28 Jul 2020
- Phase
- Early Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.
- Subjects must possess both forearms.
- Subjects must have no active skin rashes, dermatoses, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as atopic dermatitis eczema or psoriasis, anywhere on the body
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, a heart murmur, mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.
- Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products.
Who cannot join
- Participation in a clinical study in the past 7 days or current participation in another clinical study.
- Experiencing any signs/symptoms of respiratory illness, including cough, fever (body temperature of >100.0 °F) or chills, shortness of breath or difficulty breathing, persistent pain or pressure in the chest, confusion or inability to respond to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal discharge ("runny nose"), frequent sneezing, or general fatigue I body aches.
- Current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close contact within the last 2 weeks of anyone who has been diagnosed as having contracted COVID-19.
- Travel outside of the state of Montana within the last two weeks.
- History of smoking or vaping within the last 2 years.
- Have known allergies or sensitivities to latex (natural rubber), metals, inks, sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, or common antibacterial agents, particularly, chlorhexidine gluconate (CHG), ethyl alcohol, and isopropyl alcohol or topical antibiotic ointments (e.g., Neosporin® or Polysporin®).
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- Have experienced hives (raised welts) as a reaction to anything that contacted your skin, with the exception of plants known to cause reactions for most humans (e.g., poison oak or poison ivy).
- Be receiving any topical or systemic antibiotic medications during the 72-hour pre-test conditioning period or on the test day.
- Be receiving any steroids (including steroid medications used to treat asthma) other than for contraception, hormone therapy, or menopausal purposes during the 72-hour pre-test conditioning period or on the test day.
- Have any prosthetic joints anywhere in the body or any (pins, screws, plates, rods, or dental implants) anywhere in the body.
- Have any type of port (or po1iacath) or Peripherally Insetied Central Catheter (PICC).
- Be nursing a child.
- Be pregnant, or have plans to become pregnant or impregnate a sexual partner once you have consented to test in this study or during the test period.
- Any medical condition or use of any medications that, in the opinion of the Principal Investigator, or Consulting Physician should preclude patiicipation.
- Unwillingness to fulfill the performance requirements of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioscience Laboratories, Inc.
Bozeman, Montana, 59718
About this study
Official title: Clinical Evaluation of the Residual Antimicrobial Activity of One Test Product Based on the ASTM E2752 Test Method
The purpose of this study is to evaluate the residual antimicrobial efficacy of one test product as defined by the difference between the number of a challenge bacterial species recovered following exposure to the test product and the number recovered when untreated (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC #6538) (S. aureus). Testing will be carried out using a modification of the standardized test method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be assayed after application oftest material, using the forearms as a substrate.
Read the detailed description
At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this study, and will use the test product on one arm, and have the other arm untreated as the negative control. The test sites on both forearms will be inoculated with suspensions containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product drying time, and at approximately 2 hours and 4 hours following test material applications. The test sites will be sampled using the cup scrub procedure approximately 20 minutes following each inoculation. The log 10 microbial recoveries of treated versus untreated sites will be the basis for assessing the residual antimicrobial effectiveness of the test product.
- Conditions
- Bacterial Overgrowth
- Being tested
- CGB-S-100
- Keywords
- Residual, ASTME2752, Antimicrobial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGB-S-100Drug
Also called IonLAST gel (CGB-S-100 gel)
Alcohol and choline geranate
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Not described Receives: Drug: CGB-S-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant Log 10 Microbial Change 4 hours post application
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start16 Jun 2020
- Primary completion13 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial OvergrowthStudies 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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAGE Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Senior Scientist, Principal investigator, BIOSCIENCE LAB ORA TORIES, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495920
- Sponsor's protocol ID
- 2005367-150
- Status last verified
- Aug 2020
- First submitted
- 29 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Residual Antimicrobial Activity of One Test Product Based on the ASTM E2752 Test Method
- ClinicalTrials.gov ID
- NCT04495920
- Acronym / sponsor ID
- 2005367-150
- Conditions
- Bacterial Overgrowth
- Keywords
- Residual, ASTME2752, Antimicrobial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioScience Laboratories, Inc.
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 3 Aug 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.
The purpose of this study is to evaluate the residual antimicrobial efficacy of one test product as defined by the difference between the number of a challenge bacterial species recovered following exposure to the test product and the number recovered when untreated (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC #6538) (S. aureus). Testing will be carried out using a modification of the standardized test method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be assayed after application oftest material, using the forearms as a substrate.
Detailed description
At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this study, and will use the test product on one arm, and have the other arm untreated as the negative control. The test sites on both forearms will be inoculated with suspensions containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product drying time, and at approximately 2 hours and 4 hours following test material applications. The test sites will be sampled using the cup scrub procedure approximately 20 minutes following each inoculation. The log 10 microbial recoveries of treated versus untreated sites will be the basis for assessing the residual antimicrobial effectiveness of the test product.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: CGB-S-100 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects may be of either sex, between the ages of 18 and 65 years, and of any race.
- Subjects must possess both forearms.
- Subjects must have no active skin rashes, dermatoses, or breaks in the skin of the hands or forearms. Subjects must also have no inflammatory skin conditions, such as atopic dermatitis eczema or psoriasis, anywhere on the body
- Subjects must be in good general health and have no medical diagnosis of a physical condition, such as a current or recent severe illness, a heart murmur, mitral valve prolapse with heart murmur, congenital heart disease, an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, fibromyalgia, ulcerative colitis, Crohn's disease, asthma, heart disease, hypertension, or medicated multiple sclerosis.
- Subjects must have read and signed an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and List of Restricted Products.
Key exclusion criteria (15 listed)
- Participation in a clinical study in the past 7 days or current participation in another clinical study.
- Experiencing any signs/symptoms of respiratory illness, including cough, fever (body temperature of >100.0 °F) or chills, shortness of breath or difficulty breathing, persistent pain or pressure in the chest, confusion or inability to respond to external stimuli, bluish lips/face, loss of taste/smell, sore throat, headache, nasal discharge ("runny nose"), frequent sneezing, or general fatigue I body aches.
- Current diagnosis of active Coronavirus Disease 2019 (COVID-19) or have been in close contact within the last 2 weeks of anyone who has been diagnosed as having contracted COVID-19.
- Travel outside of the state of Montana within the last two weeks.
- History of smoking or vaping within the last 2 years.
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 |
|---|---|---|
| CGB-S-100Also: IonLAST gel (CGB-S-100 gel)Alcohol and choline geranate | Drug | Test product |
Primary outcome
Significant Log 10 Microbial Change 4 hours post application
Time frame: 4 hours
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 5 Aug 2020.
- 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.
Senior Scientist principal investigator
BIOSCIENCE LAB ORA TORIES, INC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CGB-S-100 in people with Bacterial Overgrowth, run by CAGE Bio Inc. 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 5 inclusion and 15 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 5 Aug 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Significant Log 10 Microbial Change 4 hours post application (time frame: 4 hours). 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 5 Aug 2020.