Evidence map›Paper›PMID 30261905›Full record

Trial reportCritical care (London, England)2018

Synbiotics modulate gut microbiota and reduce enteritis and ventilator-associated pneumonia in patients with sepsis: a randomized controlled trial.

Kentaro Shimizu, Tomoki Yamada, Hiroshi Ogura, Tomoyoshi Mohri, Takeyuki Kiguchi, Satoshi Fujimi, Takashi Asahara, Tomomi Yamada, Masahiro Ojima, Mitsunori Ikeda and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 137 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
137citing papers in PubMed, 12 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.

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

137 citing papers in PubMed, 12 syntheses or guidelines pooled it.

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  20. The gut pathobiome: a new frontier in the management of the critically ill.Journal of critical care medicine (Universitatea de Medicina si Farmacie din Targu-Mures) · 2026
    Article

77 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Kentaro ShimizuDepartment of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Osaka, 565-0871, Japan. shimiken@hp-emerg.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0003-0631-9365
Tomoki YamadaDepartment of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Osaka, 565-0871, Japan.
Hiroshi OguraDepartment of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Osaka, 565-0871, Japan.
Tomoyoshi MohriDepartment of Trauma, Critical care and Emergency medicine, Osaka General Medical Center, Osaka, Japan.
Takeyuki KiguchiDepartment of Trauma, Critical care and Emergency medicine, Osaka General Medical Center, Osaka, Japan.
Satoshi FujimiDepartment of Trauma, Critical care and Emergency medicine, Osaka General Medical Center, Osaka, Japan.
Takashi AsaharaYakult Central Institute, Kunitachi-shi, Tokyo, Japan.
Tomomi YamadaDepartment of Medical Innovation, Osaka University Hospital, Suita, Osaka, Japan.
Masahiro OjimaDepartment of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Osaka, 565-0871, Japan.
Mitsunori IkedaDepartment of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Osaka, 565-0871, Japan.
Takeshi ShimazuDepartment of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita-city, Osaka, 565-0871, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCommensal microbiota deteriorate in critically ill patients. The preventive effects of probiotic/synbiotic therapy on microbiota and septic complications have not been thoroughly clarified in patients with sepsis. The objective of this study was to evaluate whether synbiotics have effects on gut microbiota and reduce complications in mechanically ventilated patients with sepsis.

methodsSepsis patients who were mechanically ventilated in the intensive care unit (ICU) were included in this randomized controlled study. Patients receiving daily synbiotics (Bifidobacterium breve strain Yakult, Lactobacillus casei strain Shirota, and galactooligosaccharides) initiated within 3 days after admission (the Synbiotics group) were compared with patients who did not receive synbiotics (the No-Synbiotics group). The primary outcome was infectious complications including enteritis, ventilator-associated pneumonia (VAP), and bacteremia within 4 weeks from admission. The secondary outcomes included mortality within 4 weeks, fecal bacterial counts, and organic acid concentration. Enteritis was defined as the acute onset of continuous liquid stools for more than 12 h.

resultsSeventy-two patients completed this trial; 35 patients received synbiotics and 37 patients did not receive synbiotics. The incidence of enteritis was significantly lower in the Synbiotics than the No-Synbiotics group (6.3% vs. 27.0%; p < 0.05). The incidence of VAP was also significantly lower in the Synbiotics than the No-Synbiotics group (14.3% vs. 48.6%; p < 0.05). The incidence of bacteremia and mortality did not differ significantly between the two groups. In the analysis of fecal bacteria, the number of Bifidobacterium and Lactobacillus in the Synbiotics group was significantly higher than that in the No-Synbiotics group. In the analysis of fecal organic acids, total organic acid concentration, especially the amounts of acetate, were significantly greater in the Synbiotics group than in the No-Synbiotics group at the first week (p < 0.05).

conclusionsProphylactic synbiotics could modulate the gut microbiota and environment and may have preventive effects on the incidence of enteritis and VAP in patients with sepsis.

trial registrationUMIN, R000007633 . Registered on 29 September 2011.

Indexed as

AgedAged, 80 and overAPACHEBifidobacterium bifidumCritical IllnessEnteritisFemaleGastrointestinal MicrobiomeHumansIncidenceLacticaseibacillus caseiMaleMiddle AgedPneumonia, Ventilator-AssociatedProbioticsProportional Hazards ModelsDiarrheaGutMicrobiotaProbioticsSepsisShort-chain fatty acidsSynbioticsVentilator-associated pneumonia

Identifiers

PMID30261905
PMCPMC6161427

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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.