Evidence map›Paper›PMID 24628464›Full record

Trial reportAlimentary pharmacology & therapeutics2014

Randomised clinical trial: Lactobacillus GG modulates gut microbiome, metabolome and endotoxemia in patients with cirrhosis.

J S Bajaj, D M Heuman, P B Hylemon, A J Sanyal, P Puri, R K Sterling, V Luketic, R T Stravitz, M S Siddiqui, M Fuchs and 11 more

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 139 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
139citing papers in PubMed, 9 pooled it
11.3field-weighted citation impact, top 1% 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

139 citing papers in PubMed, 9 syntheses or guidelines pooled it, 270 citations in OpenAlex.

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  9. Probiotics for people with hepatic encephalopathy.The Cochrane database of systematic reviews · 2017
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  20. Frontiers in endocrinology · 2026
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79 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 4 institutions in 1 country.

J S BajajDivision of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University and McGuire VAMC, Richmond, VA, USA.
D M Heuman
P B Hylemon
A J Sanyal
P Puri
R K Sterling
V Luketic
R T Stravitz
M S Siddiqui
M Fuchs
L R Thacker
J B Wade
K Daita
S Sistrun
M B White
N A Noble
C Thorpe
G Kakiyama
W M Pandak
M Sikaroodi
P M Gillevet
Virginia Commonwealth University · USHunter Holmes McGuire VA Medical Center · USGeorge Mason University · USTufts University · US

Funding

Probiotic Yogurt for the Treatment of Minimal Hepatic EncephalopathyU01AT004428 · NCCIH · VIRGINIA COMMONWEALTH UNIVERSITY · PI BAJAJ, JASMOHAN S · 2009 to 2011
$848k
Role of Cholesterol in Non Alcoholic Fatty LiverI01BX000197 · VA · VA VETERANS ADMINISTRATION HOSPITAL · PI PANDAK, WILLIAM M · 2009 to 2021
–
BLRD VA I01 BX000197NCCIH NIH HHS U01 AT004428
6 · The paper itself

Abstract

backgroundSafety of individual probiotic strains approved under Investigational New Drug (IND) policies in cirrhosis with minimal hepatic encephalopathy (MHE) is not clear.

aimThe primary aim of this phase I study was to evaluate the safety, tolerability of probiotic Lactobacillus GG (LGG) compared to placebo, while secondary ones were to explore its mechanism of action using cognitive, microbiome, metabolome and endotoxin analysis in MHE patients.

methodsCirrhotic patients with MHE patients were randomised 1:1 into LGG or placebo BID after being prescribed a standard diet and multi-vitamin regimen and were followed up for 8 weeks. Serum, urine and stool samples were collected at baseline and study end. Safety was assessed at Weeks 4 and 8. Endotoxin and systemic inflammation, microbiome using multi-tagged pyrosequencing, serum/urine metabolome were analysed between groups using correlation networks.

resultsThirty MHE patients (14 LGG and 16 placebo) completed the study without any differences in serious adverse events. However, self-limited diarrhoea was more frequent in LGG patients. A standard diet was maintained and LGG batches were comparable throughout. Only in the LGG-randomised group, endotoxemia and TNF-α decreased, microbiome changed (reduced Enterobacteriaceae and increased Clostridiales Incertae Sedis XIV and Lachnospiraceae relative abundance) with changes in metabolite/microbiome correlations pertaining to amino acid, vitamin and secondary BA metabolism. No change in cognition was found.

conclusionsIn this phase I study, Lactobacillus GG is safe and well-tolerated in cirrhosis and is associated with a reduction in endotoxemia and dysbiosis.

Indexed as

LactobacillusAgedDiarrheaEndotoxemiaFemaleFollow-Up StudiesGastrointestinal TractHepatic EncephalopathyHumansInflammationLiver CirrhosisMaleMetabolomeMicrobiotaMiddle AgedProbioticsTumor Necrosis Factor-alpha

Identifiers

PMID24628464
PMCPMC3989370
OpenAlexW1983159706

What OpenQuestion holds

Textmetadata
LicenceTDM
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.