Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Microbiome Transplant | Experimental | Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. |
|
| Placebo Arm | Placebo Comparator | This arm will have a base moisturizer alone applied to it during the third visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Microbiome Transplant | Biological |
| ||
| Placebo Arm |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24-hours post-transplant |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Division of Dermatology | San Diego | California | 92122 | United States |
All subjects avoided any treatments and therapies that may potentially affect skin microbiome before sample collection.
Adults with AD were recruited from the University of California, San Diego (UCSD), La Jolla, CA, and the National Jewish Health (NJH), Denver, CO.
| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Microbiome Transplant and Placebo (Split-design) | Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
5 subjects with AD were enrolled in the study. Each of the subject's arms was randomly assigned to treatment with AMT or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Microbiome Transplant and Placebo (Split-design) | Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ratio to baseline S. aureus abundance | 24-hours post-transplant | arms | arms |
|
30 days after baseline visit
Participants were asked about adverse events by phone 30 days after baseline visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autologous Microbiome Transplant | Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials Unit | University of California, San Diego | 858-657-8390 | dermstudies@ucsd.edu |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Placebo (Split-design) | Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |