Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Autologous Microbial Transplant
Intervention description: Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 18-60 years of age

          3. Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka
             Diagnostic Criteria for atopic dermatitis

          4. Presence of lesional atopic dermatitis skin in both antecubital fossae

          5. Positive S. aureus colonization based on results of a skin culture taken from one of
             their AD-affected antecubital fossae

          6. Positive for antimicrobial CoNS species from non-lesional AD skin

        Exclusion Criteria:

          1. Use of any topical AD treatments (including topical steroids, topical calcineurin
             inhibitors) to either arm within one week of the Treatment visit

          2. Use of any antihistamines 7 days within one week of the Treatment visit

          3. Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment visit

          4. 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)

          5. Subjects who have taken a bleach bath within a week prior to the Treatment visit, or
             who take bleach baths during the study

          6. Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study

          7. Subjects with Netherton's syndrome or other genodermatoses that result in a defective
             epidermal barrier

          8. 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.

          9. 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

         10. Active bacterial, viral or fungal skin infections

         11. 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.

         12. Ongoing participation in another investigational trial

         13. Use of any oral or topical antibiotic for up to four weeks prior to the Treatment
             visit

         14. Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks
             of the Treatment visit.

         15. Sensitivity to or difficulty tolerating Dove fragrance-free bar soap or Cetaphil
             lotion

         16. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other
             foreign or prosthetic devices.

         17. Allergy or intolerability to soy or macadamia nuts.

         18. Participant who has a condition or is in a situation that, in the investigator's
             opinion, may put the patient at significant risk, or may significantly interfere with
             the patient's participation in the study.