Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Primary Purpose
Atopic Dermatitis Eczema
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Autologous Microbial Transplant
Sponsored by
![University of California, San Diego](https://trials-media.s3.amazonaws.com/orgs/university-of-california-san-diego.jpeg)
About this trial
This is an interventional treatment trial for Atopic Dermatitis Eczema
Eligibility Criteria
Inclusion Criteria:
- 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.
- 18-60 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
- Positive for antimicrobial CoNS species from non-lesional AD skin
Exclusion Criteria:
- Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of the Treatment visit
- Use of any antihistamines 7 days within one week of the Treatment visit
- Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment 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 Treatment visit for topical medications and antihistamines and 28 days prior to Treatment visits for oral medications)
- Subjects who have taken a bleach bath within a week prior to the Treatment visit, 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 the Treatment visit
- Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.
- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap or Cetaphil lotion
- Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.
- Allergy or intolerability to soy or macadamia nuts.
- 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.
Sites / Locations
- University of California San Diego Dermatology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active treatment
Placebo treatment
Arm Description
Outcomes
Primary Outcome Measures
Relative Abundance of Staphylococcus Aureus Compared to Baseline
Relative abundance of S. aureus 24 hours after initial treatment application (baseline).
Secondary Outcome Measures
Full Information
NCT ID
NCT03158012
First Posted
May 9, 2017
Last Updated
October 18, 2019
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT03158012
Brief Title
Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Official Title
Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Autologous Microbial Transplant
Intervention Description
Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients
Primary Outcome Measure Information:
Title
Relative Abundance of Staphylococcus Aureus Compared to Baseline
Description
Relative abundance of S. aureus 24 hours after initial treatment application (baseline).
Time Frame
24 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
18-60 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
Positive for antimicrobial CoNS species from non-lesional AD skin
Exclusion Criteria:
Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of the Treatment visit
Use of any antihistamines 7 days within one week of the Treatment visit
Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment 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 Treatment visit for topical medications and antihistamines and 28 days prior to Treatment visits for oral medications)
Subjects who have taken a bleach bath within a week prior to the Treatment visit, 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 the Treatment visit
Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.
Sensitivity to or difficulty tolerating Dove fragrance-free bar soap or Cetaphil lotion
Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.
Allergy or intolerability to soy or macadamia nuts.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gallo, MD, PhD
Organizational Affiliation
UCSD School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego Dermatology Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34132739
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
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