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

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ClinicalTrials.gov Identifier: NCT02144142
Recruitment Status : Withdrawn (This sub-study was not done because main study results reached significance.)
First Posted : May 21, 2014
Last Update Posted : November 5, 2020
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 Staphylococcal species such as Staphylococcus 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 study team will attempt to decrease S. aureus colonization and increase colonization by protective Staph species in AD patients by first culturing the bacteria on subjects' lesional AD skin. The study team will selectively grow the subject's protective Staph colonies and place them into a moisturizer. The first part of the study will determine the half-life of the bacteria-containing moisturizer. The bacteria-containing moisturizer will be applied to a subject's arm, and the subject will return at four different time points over the next three days for skin swabs of the arm that will be used to determine the amount and type of bacteria on the arm at those time points. In the second part of the study, the subject will apply moisturizer containing his own antimicrobial bacteria to one of his arms for a total of 6 times at a frequency determined by the half-life, which will be computed at the end of the first part of this experiment. The subject will return prior to the 7th application time point for skin swabs of the arm to ensure that there are still viable bacteria from the moisturizer present on the arm. In the third part of the study, each subject will receive both moisturizer as well as moisturizer plus his own antimicrobial bacteria. The subject will apply the moisturizer to one arm and the moisturizer plus bacteria to the other arm daily for a total of 15 days. Subjects will return to the clinic every 5 days for skin swabs and clinical evaluations. If the moisturizer containing bacteria is able to decrease the S. aureus colonization on subject's arms, the study team hypothesizes that subjects will have improvement of their AD symptoms.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Biological: Moisturizer with each subject's own antimicrobial bacteria Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study Evaluating the Kinetic Properties of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Study Start Date : July 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Eczema

Arm Intervention/treatment
Experimental: Moisturizer with each subject's own antimicrobial bacteria
Each subject will have a moisturizer containing their own antimicrobial bacteria species spread over their arms in the clinic
Biological: Moisturizer with each subject's own antimicrobial bacteria
Other Name: Autologous microbiome transplant cream




Primary Outcome Measures :
  1. Survival of transplanted bacteria [ Time Frame: 1 hour ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured


Secondary Outcome Measures :
  1. Survival of transplanted bacteria [ Time Frame: 4 hours ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured

  2. Survival of transplanted bacteria [ Time Frame: 8 hours ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured

  3. Survival of transplanted bacteria [ Time Frame: 24 hours ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured

  4. Survival of transplanted bacteria [ Time Frame: 48 hours ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured

  5. Survival of transplanted bacteria [ Time Frame: 4 days ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured

  6. Survival of transplanted bacteria [ Time Frame: 7 days ]
    The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured


Other Outcome Measures:
  1. Adverse events [ Time Frame: 4 hours ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded

  2. Adverse events [ Time Frame: 1 hour ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded

  3. Adverse events [ Time Frame: 8 hours ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded

  4. Adverse events [ Time Frame: 24 hours ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded

  5. Adverse events [ Time Frame: 48 hours ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded

  6. Adverse events [ Time Frame: 4 days ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded

  7. Adverse events [ Time Frame: 7 days ]
    Any adverse reactions to the antimicrobial Staph-containing moisturizer will be recorded



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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 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, treatment and follow-up visits for topical medications and 28 days prior to screening, treatment and follow-up visits and 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. cyclosporine, 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
  • Known allergy to mupirocin

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): NCT02144142


Locations
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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
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Principal Investigator: Richard L Gallo, MD, PhD University of California San Diego Division of Dermatology
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Responsible Party: Richard Gallo, Chair, Division of Dermatology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02144142    
Other Study ID Numbers: UCSD 131244.3
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Keywords provided by Richard Gallo, University of California, San Diego:
Microbiome
Atopic dermatitis
Eczema
Bacteriotherapy
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-Infective Agents
Anti-Bacterial Agents