Evidence map›Paper›PMID 29720571›Full record

Trial reportJCI insight2018

First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis.

Ian A Myles, Noah J Earland, Erik D Anderson, Ian N Moore, Mark D Kieh, Kelli W Williams, Arhum Saleem, Natalia M Fontecilla, Pamela A Welch, Dirk A Darnell and 4 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in JCI insight, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 156 papers.

0numbers the graph read from it
0cells of the map it votes in
156citing papers in PubMed
32.0field-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.

NCT04504279 phase2completednot on this mapstarted 2020, after this paper: background citation

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis

TypeinterventionalSponsorForte Biosciences, Inc.Ran2020 to 2021Enrolled154ConditionsAtopic DermatitisArmsFB-401, Placebo
NCT04936113 phase2terminatednot on this mapstarted 2021, after this paper: background citation

An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study

TypeinterventionalSponsorForte Biosciences, Inc.Ran2021 to 2021Enrolled36ConditionsAtopic DermatitisArmsFB-401
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

156 citing papers in PubMed, 306 citations in OpenAlex.

  1. Trial
  2. Topical probioticFrontiers in medicine · 2026
    Trial
  3. Trial
  4. Trial
  5. Therapeutic responses toScience translational medicine · 2020
    Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Observational
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. The emerging role of the microbiome in bladder cancer: prognostic implications and treatment response.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas · 2026
    Review
  18. Review
  19. Microbiome dysbiosis and therapeutic restoration in atopic dermatitis.Frontiers in cellular and infection microbiology · 2026
    Review
  20. Review

96 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

14 authors at 2 institutions in 1 country.

Ian A MylesLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Noah J EarlandLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Erik D AndersonLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Ian N MooreInfectious Disease and Pathogenesis Section, Comparative Medicine Branch, NIAID, NIH, Rockville, Maryland, USA.
Mark D KiehLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Kelli W WilliamsLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Arhum SaleemLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Natalia M FontecillaLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Pamela A WelchLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Dirk A DarnellLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Lisa A BarnhartLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Ashleigh A SunLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Gulbu UzelLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
Sandip K DattaLaboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Bethesda, Maryland, USA.
National Institute of Allergy and Infectious Diseases · USNational Institutes of Health · US

Funding

Host Immunity Against BacteriaZIAAI001043 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MYLES, IAN · 2009 to 2025
$18.9M
6 · The paper itself

Abstract

The underlying pathology of atopic dermatitis (AD) includes impaired skin barrier function, susceptibility to Staphylococcus aureus skin infection, immune dysregulation, and cutaneous dysbiosis. Our recent investigation into the potential role of Gram-negative skin bacteria in AD revealed that isolates of one particular commensal, Roseomonas mucosa, collected from healthy volunteers (HVs) improved outcomes in mouse and cell culture models of AD. In contrast, isolates of R. mucosa from patients with AD worsened outcomes in these models. These preclinical results suggested that interventions targeting the microbiome could provide therapeutic benefit for patients with AD. As a first test of this hypothesis in humans, 10 adult and 5 pediatric patients were enrolled in an open-label phase I/II safety and activity trial (the Beginning Assessment of Cutaneous Treatment Efficacy for Roseomonas in Atopic Dermatitis trial; BACTERiAD I/II). Treatment with R. mucosa was associated with significant decreases in measures of disease severity, topical steroid requirement, and S. aureus burden. There were no adverse events or treatment complications. We additionally evaluated differentiating bacterial metabolites and topical exposures that may contribute to the skin dysbiosis associated with AD and/or influence future microbiome-based treatments. These early results support continued evaluation of R. mucosa therapy with a placebo-controlled trial.

Indexed as

Biological TherapyMethylobacteriaceaeMicrobiotaAdolescentAdultAnimalsChildDermatitis, AtopicDysbiosisFemaleHumansMaleMiceSeverity of Illness IndexSkinStaphylococcus aureusSteroidsAllergyDermatologyImmunologySkin

Identifiers

PMID29720571
PMCPMC6012572
OpenAlexW2800473251

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.