Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis Eczema
- Sponsor
- University of California, San Diego
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Relative Abundance of Staphylococcus Aureus Compared to Baseline
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 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.
Investigators
Richard Gallo
Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects who are not pregnant or lactating. Female subjects of child-bearing potential must have a negative urine pregnancy test on the day of the screening visit in order to be eligible for the study.
- •18-60 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 S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae
- •Positive for antimicrobial CoNS species from non-lesional AD skin
Exclusion Criteria
- •Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of the Treatment visit
- •Use of any antihistamines 7 days within one week of the Treatment visit
- •Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment 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 Treatment visit for topical medications and antihistamines and 28 days prior to Treatment visits for oral medications)
- •Subjects who have taken a bleach bath within a week prior to the Treatment visit, 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
Outcomes
Primary Outcomes
Relative Abundance of Staphylococcus Aureus Compared to Baseline
Time Frame: 24 Hours
Relative abundance of S. aureus 24 hours after initial treatment application (baseline).