Evidence map›Paper›PMID 37540090›Full record

ArticleThe Journal of infectious diseases2023

Manufacturing Processes of a Purified Microbiome Therapeutic Reduce Risk of Transmission of Potential Bacterial Pathogens in Donor Stool.

Christopher W J McChalicher, Mary-Jane Lombardo, Sahil Khanna, Gregory J McKenzie, Elizabeth M Halvorsen, Sanabel Almomani, Brian Schuster, Brooke R Hasson, Barbara H McGovern, David S Ege and 1 more

Open access · hybridAbstract read
In one paragraph

Article in The Journal of infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.4field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. SER-109 (VOWSTDrugs · 2024
    Review
  7. Review
  8. Microbiota-Based Live Biotherapeutic Products forInfection and drug resistance · 2024
    Review
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

11 authors at 2 institutions in 1 country.

Christopher W J McChalicherSeres Therapeutics, Cambridge, Massachusetts, USA.
Mary-Jane LombardoSeres Therapeutics, Cambridge, Massachusetts, USA.
Sahil KhannaMayo Clinic, Rochester, Minnesota, USA.
Gregory J McKenzieSeres Therapeutics, Cambridge, Massachusetts, USA.
Elizabeth M HalvorsenSeres Therapeutics, Cambridge, Massachusetts, USA.
Sanabel AlmomaniSeres Therapeutics, Cambridge, Massachusetts, USA.
Brian SchusterSeres Therapeutics, Cambridge, Massachusetts, USA.
Brooke R HassonSeres Therapeutics, Cambridge, Massachusetts, USA.
Barbara H McGovernSeres Therapeutics, Cambridge, Massachusetts, USA.ORCID 0000-0003-4451-2393
David S EgeSeres Therapeutics, Cambridge, Massachusetts, USA.
John G AuniņšSeres Therapeutics, Cambridge, Massachusetts, USA.
Seres Therapeutics (United States) · USMayo Clinic · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough fecal microbiota transplant has been used to prevent recurrent Clostridioides difficile infection (rCDI), documented pathogen transmissions highlight inherent safety risks of minimally processed stool. We describe manufacturing processes for fecal microbiota spores, live (VOWST; VOS, formerly SER-109), a microbiota-based oral therapeutic of Firmicutes spores.

methodsBacterial inactivation kill curves were obtained after ethanol exposure for 4 model organisms spiked into process intermediates.

resultsBacterial log reduction factors ranged from 6.5 log10 to 7.4 log10 and lysis of spiked organisms occurred rapidly within 30 seconds.

conclusionsThese experiments demonstrate substantial and rapid inactivation of representative organisms, supporting the potential benefit of VOS manufacturing processes to mitigate risk.

Indexed as

Clostridioides difficileClostridium InfectionsGastrointestinal MicrobiomeMicrobiotaFecal Microbiota TransplantationFecesHumansRecurrenceClostridioides difficile infectionmicrobiomemicrobiome therapeutic

Identifiers

PMID37540090
PMCPMC10640771
OpenAlexW4385564639

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.