Evidence map›Paper›PMID 33619370›Full record

Trial reportNature medicine2021

Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial.

Teruaki Nakatsuji, Tissa R Hata, Yun Tong, Joyce Y Cheng, Faiza Shafiq, Anna M Butcher, Secilia S Salem, Samantha L Brinton, Amanda K Rudman Spergel, Keli Johnson and 7 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 169 papers.

0numbers the graph read from it
0cells of the map it votes in
169citing papers in PubMed
41.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03151148 phase1 / phase2completednot on this map

A First in Man Evaluation of the Safety and Efficacy of an Allogeneic Targeted Microbiome Transplant in Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-08)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2019Enrolled54ConditionsAtopic Dermatitis (AD)ArmsTMT Lotion, Placebo Lotion
NCT06096857 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2024 to 2027Enrolled120ConditionsAtopic Dermatitis, EczemaArmsRoseomonas mucosa (RSM2015) and Cardamom seeds, Placebo (sucrose)
3 · Its place in the literature

Who cites it

169 citing papers in PubMed, 297 citations in OpenAlex.

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109 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 5 institutions in 1 country.

Teruaki NakatsujiDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.
Tissa R HataDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.
Yun TongDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.ORCID http://orcid.org/0000-0003-2003-1843
Joyce Y ChengDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.ORCID http://orcid.org/0000-0002-7317-7486
Faiza ShafiqDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.
Anna M ButcherDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.
Secilia S SalemDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.
Samantha L BrintonDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA.
Amanda K Rudman SpergelDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-9418-7317
Keli JohnsonRho Federal Systems Division, Inc., Durham, NC, USA.
Brett JepsonRho Federal Systems Division, Inc., Durham, NC, USA.
Agustin CalatroniRho Federal Systems Division, Inc., Durham, NC, USA.
Gloria DavidRho Federal Systems Division, Inc., Durham, NC, USA.
Marco Ramirez-GamaDivision of Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.ORCID http://orcid.org/0000-0003-4572-6115
Patricia TaylorDivision of Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.
Donald Y M LeungDivision of Allergy and Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA.ORCID http://orcid.org/0000-0002-0177-3844
Richard L GalloDepartment of Dermatology, University of California, San Diego, La Jolla, CA, USA. rgallo@health.ucsd.edu.ORCID http://orcid.org/0000-0002-1401-7861
University of California San Diego · USRho (United States) · USNational Jewish Health · USNational Institutes of Health · USUC San Diego Health System · US

Funding

Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Experimental and Computational Analysis of the Human Epidemiology and Response to SARS-CoV-2 (HEROS) CohortUM1AI151958 · NIAID · NATIONAL JEWISH HEALTH · PI Donald YM Leung · 2020 to 2026
$38.3M
Targeted Microbiome Transplant in Atopic DermatitisU19AI117673 · NIAID · NATIONAL JEWISH HEALTH · PI GEHA, RAIF SALIM · 2015 to 2019
$30.6M
Cathelicidin in Skin ImmunityR37AI052453 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Richard L Gallo, Victor Nizet · 2019 to 2026
$4.6M
Microbiome Function in Atopic DermatitisU01AI152038 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Richard L Gallo · 2020 to 2026
$3.3M
Quorum sensing, diversity and skin inflammationR01AI153185 · NIAID · UNIVERSITY OF COLORADO DENVER · PI GALLO, RICHARD L, HORSWILL, ALEXANDER R · 2020 to 2024
$3.2M
Conflict and Cooperation between AMP Species on the skinR01AR076082 · NIAMS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GALLO, RICHARD L, NAKATSUJI, TERUAKI · 2019 to 2023
$2.3M
Skin Barrier and the MicrobiomeR01AR064781 · NIAMS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GALLO, RICHARD L, HATA, TISSA R · 2014 to 2018
$1.8M
Skin barrier function and the microbiomeR01AI116576 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI GALLO, RICHARD L, NAKATSUJI, TERUAKI · 2015 to 2019
$1.7M
NCATS NIH HHS UL1 TR002535NIAID NIH HHS R01 AI116576NIAID NIH HHS R01 AI153185NIAID NIH HHS R37 AI052453NIAID NIH HHS U01 AI152038NIAID NIH HHS U19 AI117673NIAID NIH HHS UM1 AI151958NIAID NIH HHS UM2 AI117870NIAMS NIH HHS R01 AR064781NIAMS NIH HHS R01 AR076082
6 · The paper itself

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 (psmα) 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 psmα 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.

Indexed as

Administration, TopicalAdolescentAdultAgedAged, 80 and overAnimalsBacterial ProteinsBacteriocinsColony Count, MicrobialDermatitis, AtopicHumansInflammationMiceMice, Inbred BALB CMicrobial Sensitivity TestsMicrobial ViabilityAgrD protein, StaphylococcusBacterial ProteinsBacteriocinsPeptides, CyclicVirulence Factors

Identifiers

PMID33619370
PMCPMC8052297
OpenAlexW3129601032

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.