Evidence map›Paper›PMID 28961980›Full record

Trial reportThe Journal of antimicrobial chemotherapy2017

A randomized controlled trial of probiotics for Clostridium difficile infection in adults (PICO).

Anna K Barker, Megan Duster, Susan Valentine, Timothy Hess, Laurie Archbald-Pannone, Richard Guerrant, Nasia Safdar

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01680874 (A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile), which is not on this map. Cited by 49 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 4 pooled it
–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.

NCT01680874 phase2completednot on this map

A Pilot Study to Examine the Role of Probiotics for Improving Outcomes of C. Difficile

TypeinterventionalSponsorUniversity of Wisconsin, MadisonRan2013 to 2015Enrolled33ConditionsClostridium DifficileArmsProbiotic, Placebo
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. The host genes influencingFrontiers in cellular and infection microbiology · 2025
    Article
  16. Bacterial live therapeutics for human diseases.Molecular systems biology · 2024
    Review
  17. Pathogens (Basel, Switzerland) · 2024
    Review
  18. Guideline for the management ofEClinicalMedicine · 2024
    Review
  19. Article
  20. 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

7 authors.

Anna K BarkerDepartment of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.
Megan DusterDivision of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
Susan ValentineDivision of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
Timothy HessDivision of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
Laurie Archbald-PannoneDivision of General, Geriatric, Palliative and Hospital Medicine, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.
Richard GuerrantDivision of Infectious Diseases and International Health, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.
Nasia SafdarDivision of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.

Funding

Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
INTEGRATED TRAINING FOR PHYSICIAN-SCIENTISTST32GM008692 · NIGMS · UNIVERSITY OF WISCONSIN-MADISON · PI BURKARD, MARK E · 1998 to 2020
$10.3M
Institutional Clinical and Translational Science AwardTL1TR000429 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$1.5M
Probiotics to Improve Outcomes of Clostridium difficileR03AG040669 · NIA · UNIVERSITY OF WISCONSIN-MADISON · PI SAFDAR, NASIA · 2012 to 2013
$146k
NCATS NIH HHS TL1 TR000429NCATS NIH HHS UL1 TR000427NIA NIH HHS R03 AG040669NIGMS NIH HHS T32 GM008692
6 · The paper itself

Abstract

backgroundClostridium difficile is the most common cause of hospital-acquired infections, responsible for >450000 infections annually in the USA. Probiotics provide a promising, well-tolerated adjunct therapy to standard C. difficile infection (CDI) treatment regimens, but there is a paucity of data regarding their effectiveness for the treatment of an initial CDI.

objectivesWe conducted a pilot randomized controlled trial of 33 participants from February 2013 to February 2015 to determine the feasibility and health outcomes of adjunct probiotic use in patients with an initial mild to moderate CDI.

methodsThe intervention was a 28 day, once-daily course of a four-strain oral probiotic capsule containing Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Bifidobacterium lactis Bi-07 and B. lactis Bl-04. The control placebo was identical in taste and appearance. Registered at clinicaltrials.gov: trial registration number = NCT01680874.

resultsProbiotic adjunct therapy was associated with a significant improvement in diarrhoea outcomes. The primary duration of diarrhoea outcome (0.0 versus 1.0 days; P = 0.039) and two exploratory outcomes, total diarrhoea days (3.5 versus 12.0 days; P = 0.005) and rate of diarrhoea (0.1 versus 0.3 days of diarrhoea/stool diary days submitted; P = 0.009), all decreased in participants with probiotic use compared with placebo. There was no significant difference in the rate of CDI recurrence or functional improvement over time between treatment groups.

conclusionsProbiotics are a promising adjunct therapy for treatment of an initial CDI and should be further explored in a larger randomized controlled trial.

Indexed as

AdultAgedAnti-Bacterial AgentsBifidobacterium animalisClostridioides difficileClostridium InfectionsCombined Modality TherapyDiarrheaDouble-Blind MethodFecesFemaleHumansLactobacillusMaleMiddle AgedPilot ProjectsAnti-Bacterial Agents

Identifiers

PMID28961980
PMCPMC5890711

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.