Trial Outcomes & Findings for Validation of the Short-term Antimicrobial Action of Transplanted Bacteria (NCT NCT01959113)

NCT ID: NCT01959113

Last Updated: 2020-06-17

Results Overview

The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 5 participants
• Primary outcome timeframe: 24-hours post-transplant
• Results posted on: 2020-06-17

Participant Flow

Adults with AD were recruited from the University of California, San Diego (UCSD), La Jolla, CA, and the National Jewish Health (NJH), Denver, CO.

All subjects avoided any treatments and therapies that may potentially affect skin microbiome before sample collection.

Unit of analysis: arms

Participant milestones

Measure	Autologous Microbiome Transplant and Placebo (Split-design) Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm.
Overall Study STARTED	5 10
Overall Study COMPLETED	5 10
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of the Short-term Antimicrobial Action of Transplanted Bacteria

Baseline characteristics by cohort

Measure	Autologous Microbiome Transplant and Placebo (Split-design) n=5 Participants Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23.8 years STANDARD_DEVIATION 2.05 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 24-hours post-transplant

The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance

Outcome measures

Measure	Placebo Arm n=5 arms This arm will have a base moisturizer alone applied to it during the third visit. Placebo Arm	Autologous Microbiome Transplant n=5 arms Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant
Relative Staphylococcus Aureus Abundance	0.13 ratio to baseline S. aureus abundance Standard Deviation 0.2	12.2 ratio to baseline S. aureus abundance Standard Deviation 10.1

Adverse Events

Autologous Microbiome Transplant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo (Split-design)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Autologous Microbiome Transplant n=5 participants at risk Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm. Autologous Microbiome Transplant	Placebo (Split-design) n=5 participants at risk Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm.
Skin and subcutaneous tissue disorders rash	0.00% 0/5 • 30 days after baseline visit Participants were asked about adverse events by phone 30 days after baseline visit.	0.00% 0/5 • 30 days after baseline visit Participants were asked about adverse events by phone 30 days after baseline visit.

Additional Information

Director of Clinical Trials Unit

University of California, San Diego

Phone: 858-657-8390

Email: dermstudies@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place