A Phase 1 interventional study of Autologous Microbiome Transplant and Placebo Arm in Atopic Dermatitis, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-17.
Sponsored by University of California, San Diego · Phase 1, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 5 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.
Biological: Autologous Microbiome Transplant
This arm will have a base moisturizer alone applied to it during the third visit.
Other: Placebo Arm
Also known as: The placebo arm will have a commercially available moisturizer applied to it.
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
Time frame: 24-hours post-transplant
Adults with AD were recruited from the University of California, San Diego (UCSD), La Jolla, CA, and the National Jewish Health (NJH), Denver, CO.
| Milestone | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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
| ratio to baseline S. aureus abundance | Placebo Arm | Autologous Microbiome Transplant |
|---|---|---|
| Relative Staphylococcus Aureus Abundance | 0.13 ± 0.2 | 12.2 ± 10.1 |
Collected over 30 days after baseline visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Autologous Microbiome Transplant | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Placebo (Split-design) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Event | Autologous Microbiome Transplant | Placebo (Split-design) |
|---|---|---|
| rashSkin and subcutaneous tissue disorders | 0/5 | 0/5 |
5 subjects with AD were enrolled in the study. Each of the subject's arms was randomly assigned to treatment with AMT or placebo.
| Age, Categorical(Participants) | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Age, Continuous(years) | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| Mean | 23.8 ± 2.05 |
| Sex: Female, Male(Participants) | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| Female | 3 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| United States | 5 |
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of California, San Diego