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

NCT03158012 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: UCSD 131244.4
• Study Type: interventional
• Target: 15
• 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 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.

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• Relative Abundance of Staphylococcus Aureus Compared to Baseline

  Relative abundance of S. aureus 24 hours after initial treatment application (baseline).

  24 Hours

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Biological: Autologous Microbial Transplant

Placebo treatment

PLACEBO COMPARATOR

Biological: Autologous Microbial Transplant

Interventions

Autologous Microbial Transplant BIOLOGICAL

Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients

Active treatment; Placebo treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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.

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

Related Publications (1)

• 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.

  PMID: 34132739 DERIVED

Results Point of Contact

• Title: Teruaki Nakatsuji
• Organization: UCSD Dermatology

tnakatsuji@ucsd.edu

8588227814

Study Officials

• Richard Gallo, MD, PhD

  UCSD School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 17, 2017
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: November 7, 2019
• Results First Posted: November 7, 2019

Record last verified: 2019-10

Locations

US (1)