Validation of the Short-term Antimicrobial Action of Transplanted Bacteria

NCT01959113 | Completed Phase 1 Results

• 1 other identifier: UCSD 131244.1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Microbiome; Bacteria transplant; Atopic dermatitis treatments

Outcome Measures

Primary Outcomes (1)

• Relative Staphylococcus Aureus Abundance

  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 as a ratio of baseline S. aureus abundance

  24-hours post-transplant

Study Arms (2)

Autologous Microbiome Transplant

EXPERIMENTAL

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 Arm

PLACEBO COMPARATOR

This arm will have a base moisturizer alone applied to it during the third visit.

Other: Placebo Arm

Interventions

Autologous Microbiome Transplant BIOLOGICAL

Autologous Microbiome Transplant

Placebo Arm OTHER

Also known as: The placebo arm will have a commercially available moisturizer applied to it.

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects who are not pregnant or lactating
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Trials Unit
• Organization: University of California, San Diego

dermstudies@ucsd.edu

858-657-8390

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Division of Dermatology

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 9, 2013
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2020-06

Locations

US (1)