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CompletedNCT03158012Updated Nov 7, 2019Results posted

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

A Phase 1 interventional study of Autologous Microbial Transplant in Atopic Dermatitis Eczema, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-11-07.

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

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Apr 2016, registered May 2017).
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
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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 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.

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Conditions studied

  • Atopic Dermatitis Eczema
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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 15 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.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female subjects who are not pregnant or lactating. Female subjects of child-bearing potential must have a negative urine pregnancy test on the day of the screening visit in order to be eligible for the study.
  2. 18-60 years of age
  3. Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis
  4. Presence of lesional atopic dermatitis skin in both antecubital fossae
  5. Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae
  6. Positive for antimicrobial CoNS species from non-lesional AD skin

Exclusion criteria

Exclusion Criteria:

  1. Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of the Treatment visit
  2. Use of any antihistamines 7 days within one week of the Treatment visit
  3. Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment visit
  4. 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 Treatment visit for topical medications and antihistamines and 28 days prior to Treatment visits for oral medications)
  5. Subjects who have taken a bleach bath within a week prior to the Treatment visit, or who take bleach baths during the study
  6. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  7. Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
  8. 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.
  9. 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
  10. Active bacterial, viral or fungal skin infections
  11. 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.
  12. Ongoing participation in another investigational trial
  13. Use of any oral or topical antibiotic for up to four weeks prior to the Treatment visit
  14. Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.
  15. Sensitivity to or difficulty tolerating Dove fragrance-free bar soap or Cetaphil lotion
  16. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.
  17. Allergy or intolerability to soy or macadamia nuts.
  18. Participant who has a condition or is in a situation that, in the investigator's opinion, may put the patient at significant risk, or may significantly interfere with the patient's participation in the study.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Active treatment

    Biological: Autologous Microbial Transplant

  • Placebo comparator
    Placebo treatment

    Biological: Autologous Microbial Transplant

Interventions

  • BiologicalAutologous Microbial Transplant

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

06

What researchers measure

Primary outcomes

  1. Relative Abundance of Staphylococcus Aureus Compared to Baseline

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

    Time frame: 24 Hours

07

Results

Posted Nov 7, 2019

Participant flow

Participant flow — Overall Study
MilestoneActive TreatmentPlacebo Treatment
Started87
Completed86
Not completed01
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryRelative Abundance of Staphylococcus Aureus Compared to Baseline

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

Time frame:
24 Hours
Reported as:
Mean · Relative abundance of S. aureus
Relative Abundance of Staphylococcus Aureus Compared to Baseline
Relative abundance of S. aureusActive TreatmentPlacebo Treatment
Relative Abundance of Staphylococcus Aureus Compared to Baseline0.106 (0 to 0.4)12.9 (1.5 to 25)

Adverse events

Collected over 1 Month(Screening-Last Phone Call). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active Treatment0/8 (0%)0/8 (0%)1/8 (12.5%)
Placebo Treatment0/6 (0%)0/6 (0%)2/6 (33.3%)
Most frequent other events
Most frequent other events
EventActive TreatmentPlacebo Treatment
RashGeneral disorders1/82/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Active TreatmentPlacebo TreatmentTotal
<=18 years123
Between 18 and 65 years7411
>=65 years000
Age, Continuous
Age, Continuous(years)Active TreatmentPlacebo TreatmentTotal
Mean29.63 ± 14.3025.5 ± 12.2427.85 ± 13.12
Sex: Female, Male
Sex: Female, Male(Participants)Active TreatmentPlacebo TreatmentTotal
Female549
Male325
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Active TreatmentPlacebo TreatmentTotal
Hispanic or Latino011
Not Hispanic or Latino8513
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Active TreatmentPlacebo TreatmentTotal
American Indian or Alaska Native000
Asian437
Native Hawaiian or Other Pacific Islander000
Black or African American000
White325
More than one race112
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Active TreatmentPlacebo TreatmentTotal
United States8614
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Study locations

1 site
  • University of California San Diego Dermatology Clinic
    San Diego, California 92122, United States
09

References and documents

Publications

  • Nakatsuji T, Gallo RL, Shafiq F, Tong Y, Chun K, Butcher AM, Cheng JY, Hata TR. Use of Autologous Bacteriotherapy to Treat Staphylococcus aureus in Patients With Atopic Dermatitis: A Randomized Double-blind Clinical Trial. JAMA Dermatol. 2021 Jun 16;157(8):978-82. doi: 10.1001/jamadermatol.2021.1311. Online ahead of print. PubMed 34132739 ↗

Study documents

  • Protocol and statistical analysis plan · May 19, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03158012
Lead sponsor
University of California, San Diego
Responsible party
Richard Gallo (Professor, University of California, San Diego) — Principal investigator
First posted
May 17, 2017
Start date
Apr 2016
Primary completion
Dec 2017
Completion
Aug 2018
Results posted
Nov 7, 2019
Last update
Nov 7, 2019

Study contacts

Richard Gallo, MD, PhD
principal investigator · UCSD School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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