Trial Outcomes & Findings for Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients (NCT NCT03158012)

NCT ID: NCT03158012

Last Updated: 2019-11-07

Results Overview

Relative abundance of S. aureus 24 hours after initial treatment application (baseline).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 15 participants
• Primary outcome timeframe: 24 Hours
• Results posted on: 2019-11-07

Participant Flow

Participant milestones

Measure	Active Treatment Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients	Placebo Treatment Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
Overall Study STARTED	8	7
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Active Treatment Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients	Placebo Treatment Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Active Treatment n=8 Participants Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients	Placebo Treatment n=6 Participants Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.63 years STANDARD_DEVIATION 14.30 • n=5 Participants	25.5 years STANDARD_DEVIATION 12.24 • n=7 Participants	27.85 years STANDARD_DEVIATION 13.12 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Hours

Relative abundance of S. aureus 24 hours after initial treatment application (baseline).

Outcome measures

Measure	Active Treatment n=8 Participants Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients	Placebo Treatment n=6 Participants Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
Relative Abundance of Staphylococcus Aureus Compared to Baseline	0.106 Relative abundance of S. aureus Interval 0.0 to 0.4	12.9 Relative abundance of S. aureus Interval 1.5 to 25.0

Adverse Events

Active Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Treatment n=8 participants at risk Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients	Placebo Treatment n=6 participants at risk Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients
General disorders Rash	12.5% 1/8 • Number of events 1 • 1 Month(Screening-Last Phone Call)	33.3% 2/6 • Number of events 2 • 1 Month(Screening-Last Phone Call)

Additional Information

Teruaki Nakatsuji

UCSD Dermatology

Phone: 8588227814

Email: tnakatsuji@ucsd.edu

Results disclosure agreements

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