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CompletedNCT01959113Updated Jun 17, 2020Results posted

Validation of the Short-term Antimicrobial Action of Transplanted Bacteria

A Phase 1 interventional study of Autologous Microbiome Transplant and Placebo Arm in Atopic Dermatitis, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-17.

Sponsored by University of California, San Diego · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 by protective Staph species in AD patients. First the investigator will capture the bacteria on subjects' lesional AD 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, and the moisturizer alone (without bacteria) to the other arm. The investigator will then do a quantitative wash of the bacteria growing on each arm one day later in order to determine whether the S. aureus abundance was affected by the application of the transplanted bacteria.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Microbiome
  • Bacteria transplant
  • Atopic dermatitis treatments
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 5 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female subjects who are not pregnant or lactating
  • 18-80 years of age
  • Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis
  • Presence of lesional atopic dermatitis skin in both antecubital fossae
  • Positive methicillin-sensitive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit

Exclusion criteria

Exclusion Criteria:

  • Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit
  • Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit
  • 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 screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
  • Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
  • 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.
  • 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
  • Active bacterial, viral or fungal skin infections
  • 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.
  • Ongoing participation in another investigational trial
  • Use of any oral or topical antibiotic for up to four weeks prior to screening
  • Use of any systemic immunosuppressive therapy (e.g. cyclosporin, methotrexate, etc.) within four weeks of screening.
  • Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Dial antibacterial liquid soap, Cetaphil lotion, or alcohol-based cleaners
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Autologous Microbiome Transplant

    Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.

    Biological: Autologous Microbiome Transplant

  • Placebo comparator
    Placebo Arm

    This arm will have a base moisturizer alone applied to it during the third visit.

    Other: Placebo Arm

Interventions

  • BiologicalAutologous Microbiome Transplant
  • OtherPlacebo Arm

    Also known as: The placebo arm will have a commercially available moisturizer applied to it.

06

What researchers measure

Primary outcomes

  1. Relative Staphylococcus Aureus Abundance

    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

    Time frame: 24-hours post-transplant

07

Results

Posted Jun 17, 2020

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.

Participant flow — Overall Study
MilestoneAutologous Microbiome Transplant and Placebo (Split-design)
Started5
Completed5
Not completed0

Outcome measures

PrimaryRelative Staphylococcus Aureus Abundance

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

Time frame:
24-hours post-transplant
Reported as:
Mean · ratio to baseline S. aureus abundance
Relative Staphylococcus Aureus Abundance
ratio to baseline S. aureus abundancePlacebo ArmAutologous Microbiome Transplant
Relative Staphylococcus Aureus Abundance0.13 ± 0.212.2 ± 10.1

Adverse events

Collected over 30 days after baseline visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Autologous Microbiome Transplant0/5 (0%)0/5 (0%)0/5 (0%)
Placebo (Split-design)0/5 (0%)0/5 (0%)0/5 (0%)
Most frequent other events
Most frequent other events
EventAutologous Microbiome TransplantPlacebo (Split-design)
rashSkin and subcutaneous tissue disorders0/50/5

Baseline characteristics

5 subjects with AD were enrolled in the study. Each of the subject's arms was randomly assigned to treatment with AMT or placebo.

Age, Categorical
Age, Categorical(Participants)Autologous Microbiome Transplant and Placebo (Split-design)
<=18 years0
Between 18 and 65 years5
>=65 years0
Age, Continuous
Age, Continuous(years)Autologous Microbiome Transplant and Placebo (Split-design)
Mean23.8 ± 2.05
Sex: Female, Male
Sex: Female, Male(Participants)Autologous Microbiome Transplant and Placebo (Split-design)
Female3
Male2
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Autologous Microbiome Transplant and Placebo (Split-design)
Hispanic or Latino0
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Autologous Microbiome Transplant and Placebo (Split-design)
American Indian or Alaska Native0
Asian3
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Autologous Microbiome Transplant and Placebo (Split-design)
United States5
08

Study locations

1 site
  • UCSD Division of Dermatology
    San Diego, California 92122, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01959113
Lead sponsor
University of California, San Diego
Responsible party
Richard Gallo (Professor and Chair, Division of Dermatology, University of California, San Diego) — Principal investigator
First posted
Oct 9, 2013
Start date
Jan 2015
Primary completion
Jun 2016
Completion
Jun 2016
Results posted
Jun 17, 2020
Last update
Jun 17, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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