Evidence map›Paper›PMID 37539715›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Prevalence of Comorbid Factors in Patients With Recurrent Clostridioides difficile Infection in ECOSPOR III, a Randomized Trial of an Oral Microbiota-Based Therapeutic.

Charles S Berenson, Bret Lashner, Louis Y Korman, Elizabeth Hohmann, Abhishek Deshpande, Thomas J Louie, Matthew Sims, Darrell Pardi, Colleen S Kraft, Elaine E L Wang and 12 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
4.1field-weighted citation impact, top 5% 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

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Review
  3. The evolving landscape of live biotherapeutics in the treatment of Clostridioides difficile infection.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025
    Review
  4. A Review of Therapies forAntibiotics (Basel, Switzerland) · 2024
    Review
  5. Article
  6. Review
  7. Review
  8. Clinical microbiology reviews · 2024
    Review
  9. Article
  10. SER-109 (VOWSTDrugs · 2024
    Review
  11. Review
  12. [Antibiotic stewardship].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2023
    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

22 authors at 12 institutions in 2 countries.

Charles S BerensonVeterans Affairs Western New York Healthcare System, University at Buffalo, New York, New York, USA.
Bret LashnerGastroenterology Division, Cleveland Clinic, Ohio, USA.
Louis Y KormanGastroenterology and Hepatology, Chevy Chase Clinical Research, Chevy Chase, Maryland, USA.
Elizabeth HohmannInfectious Diseases Division, Massachusetts General Hospital, Boston, Massachusetts, USA.
Abhishek DeshpandeGastroenterology Division, Cleveland Clinic, Ohio, USA.
Thomas J LouieDepartment of Microbiology and Infectious Diseases, Cumming School of Medicine, University of Calgary, Alberta, Canada.
Matthew SimsSection of Infectious Diseases and International Medicine, Department of Internal Medicine, Beaumont Royal Oak, Royal Oak, Michigan, USA.
Darrell PardiDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Colleen S KraftDivision of Infectious Diseases, Department of Pathology and Laboratory Medicine, Emory University, Atlanta, Georgia, USA.
Elaine E L WangClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.
Stuart H CohenDivision of Infectious Diseases, University of California, Davis Health, Sacramento, California, USA.
Paul FeuerstadtDivision of Digestive Disease, Yale University School of Medicine, New Haven, Connecticut, USA.
Caterina OnetoVanguard Gastroenterology, New York, New York, USA.
Bharat MisraBorland-Groover Clinic, P.A., Jacksonville, Florida, USA.
John PullmanMercury Street Medical, Butte, Montana, USA.
Ananya DeClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.
Asli MemisogluClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.
David A LombardiClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.
Brooke R HassonClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.
Barbara H McGovernClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.ORCID 0000-0003-4451-2393
Lisa von MoltkeClinical Development, Seres Therapeutics, Cambridge, Massachusetts, USA.
Christine H LeeDepartment of Microbiology and Infectious Diseases, Island Medical Program, University of British Columbia and University of Victoria, British Columbia, Canada.
Seres Therapeutics (United States) · USCleveland Clinic · USBorland Groover Clinic · USEmory University · USMassachusetts General Hospital · USMayo Clinic · USOakland University · USUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of California, Davis · USVA Western New York Healthcare System · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundAlthough comorbidities are risk factors for recurrent Clostridioides difficile infection (rCDI), many clinical trials exclude patients with medical conditions such as malignancy or immunosuppression. In a phase 3, double-blind, placebo-controlled, randomized trial (ECOSPOR III), fecal microbiota spores, live (VOWST, Seres Therapeutics; hereafter "VOS," formerly SER-109), an oral microbiota therapeutic, significantly reduced the risk of rCDI at week 8. We evaluated the efficacy of VOS compared with placebo in patients with comorbidities and other risk factors for rCDI.

methodsAdults with rCDI were randomized to receive VOS or placebo (4 capsules daily for 3 days) following standard-of-care antibiotics. In this post hoc analysis, the rate of rCDI through week 8 was assessed in VOS-treated participants compared with placebo for subgroups including (i) Charlson comorbidity index (CCI) score category (0, 1-2, 3-4, ≥5); (ii) baseline creatinine clearance (<30, 30-50, >50 to 80, or >80 mL/minute); (iii) number of CDI episodes, inclusive of the qualifying episode (3 and ≥4); (iv) exposure to non-CDI-targeted antibiotics after dosing; and (v) acid-suppressing medication use at baseline.

resultsOf 281 participants screened, 182 were randomized (59.9% female; mean age, 65.5 years). Comorbidities were common with a mean overall baseline age-adjusted CCI score of 4.1 (4.1 in the VOS arm and 4.2 in the placebo arm). Across all subgroups analyzed, VOS-treated participants had a lower relative risk of recurrence compared with placebo.

conclusionsIn this post hoc analysis, VOS reduced the risk of rCDI compared with placebo, regardless of baseline characteristics, concomitant medications, or comorbidities.

Indexed as

Clostridioides difficileClostridium InfectionsMicrobiotaAdultAgedAnti-Bacterial AgentsFemaleHumansMalePrevalenceRecurrenceAnti-Bacterial AgentsClostridioides difficile infectioncomorbiditiesmicrobiome therapeuticsSER-109VOWST

Identifiers

PMID37539715
PMCPMC10686959
OpenAlexW4385562360

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.