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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 of protective Staph species in AD patients. First the investigator will capture the bacteria on subjects' 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 for one week. Some subjects will receive placebo, which is the moisturizer alone (without bacteria). The investigator will then swab the arms at specified time points during and after the one week application in order to determine whether the S. aureus abundance was affected by the application of the transplanted bacteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Active Comparator |
| |
| Placebo treatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Microbial Transplant | Biological | Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Abundance of Staphylococcus Aureus Compared to Baseline | Relative abundance of S. aureus 24 hours after initial treatment application (baseline). | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Gallo, MD, PhD | UCSD School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Dermatology Clinic | San Diego | California | 92122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34132739 | Derived | Nakatsuji T, Gallo RL, Shafiq F, Tong Y, Chun K, Butcher AM, Cheng JY, Hata TR. Use of Autologous Bacteriotherapy to Treat Staphylococcus aureus in Patients With Atopic Dermatitis: A Randomized Double-blind Clinical Trial. JAMA Dermatol. 2021 Jun 16;157(8):978-82. doi: 10.1001/jamadermatol.2021.1311. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients |
| FG001 | Placebo Treatment | Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients |
| BG001 | Placebo Treatment | Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients |
| 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 Abundance of Staphylococcus Aureus Compared to Baseline | Relative abundance of S. aureus 24 hours after initial treatment application (baseline). | Posted | Mean | Full Range | Relative abundance of S. aureus | 24 Hours |
|
1 Month(Screening-Last Phone Call)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | General disorders | Non-systematic Assessment | Rash reported in treatment area only. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teruaki Nakatsuji | UCSD Dermatology | 8588227814 | tnakatsuji@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2016 | Jul 29, 2019 | Prot_SAP_000.pdf |
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| BG002 | Total | Total of all reporting groups |
| 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 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Placebo Treatment | Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients | 0 | 6 | 0 | 6 | 2 | 6 |
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