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

NCT02144142 | Withdrawn Phase 2

• 1 other identifier: UCSD 131244.3
• Study Type: interventional
• Target: N/A
• 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 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.

Conditions

Atopic Dermatitis; Eczema

Keywords

Microbiome; Atopic dermatitis; Eczema; Bacteriotherapy

Outcome Measures

Primary Outcomes (1)

• Survival of transplanted bacteria

  The amount of the subject's own antimicrobial Staph species that were transplanted onto the subject will be measured

  1 hour

Secondary Outcomes (6)

• Survival of transplanted bacteria

  4 hours

• Survival of transplanted bacteria

  8 hours

• Survival of transplanted bacteria

  24 hours

• Survival of transplanted bacteria

  48 hours

• Survival of transplanted bacteria

  4 days

Other Outcomes (7)

• Adverse events

  4 hours

• Adverse events

  1 hour

• Adverse events

  8 hours

Study Arms (1)

Moisturizer with each subject's own antimicrobial bacteria

EXPERIMENTAL

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

Interventions

Moisturizer with each subject's own antimicrobial bacteria BIOLOGICAL

Also known as: Autologous microbiome transplant cream

Moisturizer with each subject's own antimicrobial bacteria

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 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. 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Dermatology Clinic

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

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

Study Officials

• Richard L Gallo, MD, PhD

  University of California San Diego Division of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of Dermatology

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: July 1, 2015
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

US (1)