Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Microbiome Transplant
Placebo Arm
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Microbiome, Bacteria transplant, Atopic dermatitis treatments
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects who are not pregnant or lactating
- 18-80 years of age
- Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis
- Presence of lesional atopic dermatitis skin in both antecubital fossae
- Positive methicillin-sensitive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit
Exclusion Criteria:
- Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit
- Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit
- Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion criteria (one week prior to the screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
- Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
- 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
- Active bacterial, viral or fungal skin infections
- Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
- Ongoing participation in another investigational trial
- Use of any oral or topical antibiotic for up to four weeks prior to screening
- Use of any systemic immunosuppressive therapy (e.g. cyclosporin, methotrexate, etc.) within four weeks of screening.
- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Dial antibacterial liquid soap, Cetaphil lotion, or alcohol-based cleaners
Sites / Locations
- UCSD Division of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Autologous Microbiome Transplant
Placebo Arm
Arm Description
Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.
This arm will have a base moisturizer alone applied to it during the third visit.
Outcomes
Primary Outcome Measures
Relative Staphylococcus Aureus Abundance
The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance
Secondary Outcome Measures
Full Information
NCT ID
NCT01959113
First Posted
September 30, 2013
Last Updated
June 15, 2020
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01959113
Brief Title
Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
Official Title
Phase 1 Study of the Short-term Antimicrobial Action of Transplanted Bacteria in Adult Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections. In addition, research in the investigator's lab has shown that these patients have fewer protective antimicrobial Staphylococcal species such as Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides that play a role in protecting the skin from invading pathogens. In this study, the investigator will attempt to decrease S. aureus colonization and increase colonization by protective Staph species in AD patients. First the investigator will capture the bacteria on subjects' lesional AD skin. Next the investigator will selectively grow the subject's antimicrobial Staphylococcal colonies and place them into a base moisturizer. The moisturizer plus bacteria will be applied to one of the subject's arms, and the moisturizer alone (without bacteria) to the other arm. The investigator will then do a quantitative wash of the bacteria growing on each arm one day later in order to determine whether the S. aureus abundance was affected by the application of the transplanted bacteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Microbiome, Bacteria transplant, Atopic dermatitis treatments
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Microbiome Transplant
Arm Type
Experimental
Arm Description
Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
This arm will have a base moisturizer alone applied to it during the third visit.
Intervention Type
Biological
Intervention Name(s)
Autologous Microbiome Transplant
Intervention Type
Other
Intervention Name(s)
Placebo Arm
Other Intervention Name(s)
The placebo arm will have a commercially available moisturizer applied to it.
Primary Outcome Measure Information:
Title
Relative Staphylococcus Aureus Abundance
Description
The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance
Time Frame
24-hours post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects who are not pregnant or lactating
18-80 years of age
Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis
Presence of lesional atopic dermatitis skin in both antecubital fossae
Positive methicillin-sensitive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit
Exclusion Criteria:
Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit
Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit
Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion criteria (one week prior to the screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
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
Active bacterial, viral or fungal skin infections
Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
Ongoing participation in another investigational trial
Use of any oral or topical antibiotic for up to four weeks prior to screening
Use of any systemic immunosuppressive therapy (e.g. cyclosporin, methotrexate, etc.) within four weeks of screening.
Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Dial antibacterial liquid soap, Cetaphil lotion, or alcohol-based cleaners
Facility Information:
Facility Name
UCSD Division of Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
We'll reach out to this number within 24 hrs