COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158012
Recruitment Status : Completed
First Posted : May 17, 2017
Results First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Richard Gallo, University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Biological: Autologous Microbial Transplant Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Active treatment Biological: Autologous Microbial Transplant
Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients

Placebo Comparator: Placebo treatment Biological: Autologous Microbial Transplant
Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients




Primary Outcome Measures :
  1. Relative Abundance of Staphylococcus Aureus Compared to Baseline [ Time Frame: 24 Hours ]
    Relative abundance of S. aureus 24 hours after initial treatment application (baseline).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158012


Locations
Layout table for location information
United States, California
University of California San Diego Dermatology Clinic
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Richard Gallo, MD, PhD UCSD School of Medicine
  Study Documents (Full-Text)

Documents provided by Richard Gallo, University of California, San Diego:
Layout table for additonal information
Responsible Party: Richard Gallo, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03158012    
Other Study ID Numbers: UCSD 131244.4
First Posted: May 17, 2017    Key Record Dates
Results First Posted: November 7, 2019
Last Update Posted: November 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases