Evidence map›Paper›PMID 38457115›Full record

ArticleDigestive diseases and sciences2024

Successful Treatment of Recurrent Clostridioides difficile Infection Using a Novel, Drinkable, Oral Formulation of Fecal Microbiota.

Michael J Sadowsky, Michael Matson, Prince P Mathai, Maradi Pho, Christopher Staley, Clayton Evert, Melissa Weldy, Alexander Khoruts

Abstract read
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In one paragraph

Article in Digestive diseases and sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Microbiome Therapeutics for Clostridioides difficile Infection.Infectious disease clinics of North America · 2025
    Review
  5. 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

8 authors.

Michael J Sadowsky *BioTechnology Institute, University of Minnesota, St. Paul, MN, USA.
Michael MatsonDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, 3-184 Wallin Medical BioSciences Building, 2101 6th St. S.E., Minneapolis, MN, 55416, USA.
Prince P MathaiBioTechnology Institute, University of Minnesota, St. Paul, MN, USA.
Maradi PhoDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, 3-184 Wallin Medical BioSciences Building, 2101 6th St. S.E., Minneapolis, MN, 55416, USA.
Christopher StaleyBioTechnology Institute, University of Minnesota, St. Paul, MN, USA.
Clayton EvertDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, 3-184 Wallin Medical BioSciences Building, 2101 6th St. S.E., Minneapolis, MN, 55416, USA.
Melissa WeldyDepartment of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota, 3-184 Wallin Medical BioSciences Building, 2101 6th St. S.E., Minneapolis, MN, 55416, USA.
Alexander Khoruts *BioTechnology Institute, University of Minnesota, St. Paul, MN, USA. khoru001@umn.edu.ORCID http://orcid.org/0000-0002-3205-3188

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFecal microbiota transplants can be administered orally in encapsulated form or require invasive procedures to administer liquid formulations. There is a need for an oral liquid formulation of fecal microbiota for patients who are unable to swallow capsules, especially if they require multiple, repeated administrations.

aimsThese studies were conducted to develop a protocol to manufacture an organoleptically acceptable powdered fecal microbiota formulation that can be suspended in a liquid carrier and used for fecal microbiota transplantation.

methodsSeveral processing steps were investigated, including extra washes of microbiota prior to lyophilization and an addition of a flavoring agent. The viability of bacteria in the transplant formulation was tested using live/dead microscopy staining and engraftment into antibiotic-treated mice. After development of a clinical protocol for suspension of the powdered microbiota, the new formulation was tested in three elderly patients with recurrent Clostridioides difficile infections and who have difficulties in swallowing capsules. Changes in the microbial community structure in one of the patients were characterized using 16S rRNA gene profiling and engraftment analysis.

resultsThe processing steps used to produce an organoleptically acceptable suspension of powdered fecal microbiota did not result in loss of its viability. The powder could be easily suspended in a liquid carrier. The use of the new formulation was associated with abrogation of the cycle of C. difficile infection recurrences in the three patients.

conclusionWe developed a novel organoleptically acceptable liquid formulation of fecal microbiota that is suitable for use in clinical trials for patients with difficulties in swallowing capsules.

Indexed as

Fecal Microbiota TransplantationAdministration, OralAgedAged, 80 and overAnimalsClostridioides difficileClostridium InfectionsFecesFemaleGastrointestinal MicrobiomeHumansMaleMicePowdersRecurrenceTreatment OutcomePowdersFecal microbiota transplantation (FMT)OrganolepticPediatric patientsRecurrent Clostridioides difficile infection

Identifiers

PMID38457115

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Registered trials

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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.