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Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial
- Source :
- Nature medicine, vol 27, iss 4, Nat Med
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- Staphylococcus aureus colonizes patients with atopic dermatitis (AD) and exacerbates disease by promoting inflammation. The present study investigated the safety and mechanisms of action of Staphylococcus hominis A9 (ShA9), a bacterium isolated from healthy human skin, as a topical therapy for AD. ShA9 killed S. aureus on the skin of mice and inhibited expression of a toxin from S. aureus (psmĪ±) that promotes inflammation. A first-in-human, phase 1, double-blinded, randomized 1-week trial of topical ShA9 or vehicle on the forearm skin of 54 adults with S. aureus-positive AD (NCT03151148) met its primary endpoint of safety, and participants receiving ShA9 had fewer adverse events associated with AD. Eczema severity was not significantly different when evaluated in all participants treated with ShA9 but a significant decrease in S. aureus and increased ShA9 DNA were seen and met secondary endpoints. Some S. aureus strains on participants were not directly killed by ShA9, but expression of mRNA for psmĪ± was inhibited in all strains. Improvement in local eczema severity was suggested by post-hoc analysis of participants with S. aureus directly killed by ShA9. These observations demonstrate the safety and potential benefits of bacteriotherapy for AD.
- Subjects :
- 0301 basic medicine
Transcription, Genetic
Administration, Topical
Colony Count
Colony Count, Microbial
Dermatitis
Human skin
medicine.disease_cause
Medical and Health Sciences
Mice
Microbial
0302 clinical medicine
Bacteriocins
Staphylococcus hominis
80 and over
Clinical endpoint
Inbred BALB C
Skin
Aged, 80 and over
Mice, Inbred BALB C
Cyclic
biology
Eczema / Atopic Dermatitis
General Medicine
Atopic dermatitis
Staphylococcal Infections
Middle Aged
Treatment Outcome
Infectious Diseases
Topical
Staphylococcus aureus
6.1 Pharmaceuticals
030220 oncology & carcinogenesis
Administration
Transcription
Bacteriotherapy
Adult
Adolescent
Virulence Factors
Clinical Trials and Supportive Activities
Immunology
Microbial Sensitivity Tests
Peptides, Cyclic
Article
Atopic
General Biochemistry, Genetics and Molecular Biology
Dermatitis, Atopic
Young Adult
03 medical and health sciences
Bacterial Proteins
Genetic
Clinical Research
medicine
Animals
Humans
Adverse effect
Aged
Inflammation
Microbial Viability
business.industry
Reproducibility of Results
Evaluation of treatments and therapeutic interventions
medicine.disease
biology.organism_classification
Clinical trial
Emerging Infectious Diseases
030104 developmental biology
Peptides
business
Subjects
Details
- ISSN :
- 1546170X and 10788956
- Volume :
- 27
- Database :
- OpenAIRE
- Journal :
- Nature Medicine
- Accession number :
- edsair.doi.dedup.....231f8f9816d9ad7c24f68313882dce01