CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Autologous Microbial Transplantbiological
Likely dose
Twice-daily topical application of autologous microbial transplant to ventral armsAI-extracted
Key inclusion· 5
  • Age 18-60 years
  • Diagnosis of atopic dermatitis for at least 6 months using Hanifin and Rajka Diagnostic Criteria
  • Presence of lesional atopic dermatitis skin in both antecubital fossae (inner elbows)
  • Positive S. aureus colonization from skin culture of AD-affected antecubital fossa
Key exclusion· 14
  • Use of topical AD treatments (steroids, calcineurin inhibitors) to either arm within one week of Treatment visit
  • Use of antihistamines within one week of Treatment visit
  • Use of oral/systemic AD therapies (steroids) within 28 days of Treatment visit
  • Severe AD that would worsen significantly from holding usual topical/oral AD medications per washout periods

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03158012
NCT03158012Phase 1Completed

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

University of California, San Diego·interventional·Posted May 17, 2017·Updated Nov 7, 2019

In Brief

A Phase 1 clinical trial evaluating Autologous Microbial Transplant for Atopic Dermatitis Eczema. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartApr 1, 2016
Primary CompletionDec 1, 2017
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.1 years ago

Interventions

Autologous Microbial Transplantbiological

Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients