NCT03158012

Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis Eczema

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Microbial Transplant	Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2018-08-01
• First posted: 2017-05-17
• Last updated: 2019-11-07
• Results posted: 2019-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study