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Validation of the Short-term Antimicrobial Action of Transplanted Bacteria

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ClinicalTrials.gov Identifier: NCT01959113
Recruitment Status : Active, not recruiting
First Posted : October 9, 2013
Last Update Posted : June 4, 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 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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Autologous Microbiome Transplant Other: Placebo Arm Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Short-term Antimicrobial Action of Transplanted Bacteria in Adult Patients With Atopic Dermatitis
Study Start Date : January 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Eczema

Arm Intervention/treatment
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
Other Name: The placebo arm will have a commercially available moisturizer applied to it.




Primary Outcome Measures :
  1. Staphylococcus aureus abundance [ Time Frame: 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


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 24 hours post-transplant ]
    Any adverse events associated with use of the autologous microbiome transplant cream will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

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): NCT01959113


Locations
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United States, California
UCSD Division of Dermatology
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: Richard Gallo, Professor and Chair, Division of Dermatology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01959113     History of Changes
Other Study ID Numbers: UCSD 131244.1
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Keywords provided by Richard Gallo, University of California, San Diego:
Microbiome
Bacteria transplant
Atopic dermatitis treatments
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents