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

NCT ID: NCT03158012

Last Updated: 2019-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active treatment

Group Type: ACTIVE_COMPARATOR

Autologous Microbial Transplant

Intervention Type: BIOLOGICAL

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

Placebo treatment

Group Type: PLACEBO_COMPARATOR

Autologous Microbial Transplant

Intervention Type: BIOLOGICAL

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

Interventions

Autologous Microbial Transplant

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 18-60 years of age

3. Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis

4. Presence of lesional atopic dermatitis skin in both antecubital fossae

5. Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae

6. Positive for antimicrobial CoNS species from non-lesional AD skin

Exclusion Criteria

1. Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of the Treatment visit

2. Use of any antihistamines 7 days within one week of the Treatment visit

3. Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment visit

5. Subjects who have taken a bleach bath within a week prior to the Treatment visit, or who take bleach baths during the study

6. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study

7. Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier

8. 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.

9. 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

10. Active bacterial, viral or fungal skin infections

11. 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.

12. Ongoing participation in another investigational trial

13. Use of any oral or topical antibiotic for up to four weeks prior to the Treatment visit

14. Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks of the Treatment visit.

15. Sensitivity to or difficulty tolerating Dove fragrance-free bar soap or Cetaphil lotion

16. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices.

17. Allergy or intolerability to soy or macadamia nuts.

18. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Richard Gallo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Gallo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSD School of Medicine

Locations

University of California San Diego Dermatology Clinic

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34132739 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UCSD 131244.4

Identifier Type: -

Identifier Source: org_study_id