Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Autologous Microbiome Transplant; Placebo Arm
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Microbiome; Bacteria transplant; Atopic dermatitis treatments

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.
    

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