Review for 10.1186/s12876-021-01660-5 (2021)

Reviewer’s report
Title: 
A Randomised Placebo Controlled Trial of VSL#3® Probiotic on
Biomarkers of Cardiovascular Risk and Liver Injury in Non-alcoholic Fatty
Liver Disease
Version: 
1 
Date: 
07 Jul 2020
Reviewer's report:
PEER REVIEWER ASSESSMENTS: 
OBJECTIVE - Full research articles: is there a clear objective that addresses a
testable research question(s) (brief or other article types: is there a clear
objective)?
Yes - there is a clear objective
DESIGN - Is the current approach (including controls and analysis protocols)
appropriate for the objective?
Yes - the approach is appropriate
EXECUTION - Are the experiments and analyses performed with technical rigor
to allow confidence in the results?
Yes - experiments and analyses were performed appropriately
STATISTICS - Is the use of statistics in the manuscript appropriate?
Not sure - I am not able to assess the statistics in this study
INTERPRETATION - Is the current interpretation/discussion of the results
reasonable and not overstated?
No - there are minor issues
OVERALL MANUSCRIPT POTENTIAL - Is the current version of this work
technically sound? If not, can revisions be made to make the work technically
sound?
Probably - with minor revisions
PEER REVIEWER COMMENTS: 
GENERAL COMMENTS: 
The manuscript entitled, "A Randomized Placebo Controlled Trial of VSL # 3®
Probiotic on biomarkers of Cardiovascular Risk and Liver Injury in Non-
Alcoholic Fatty Liver Disease" is correctly written although it has a few of my
questions and suggestions to the Authors prior to publication.
REQUESTED REVISIONS: 
A few questions and suggestions:
1. The term "biomarker" is used in the title, and "marker" and "biophysical
marker" are used in the text. My suggestion is to unify this.
2. In the Abstract, it is not necessary for the commercial name to be
accompanied by the manufacturer (VSL # 3 ® (Danisco Inc.), it is better to say
"probiotic supplement").
3. The two key words are not according to the MeSH nomenclature
(cardiovascular risk, acoustic structure quantification). Transaminases are
according to MeSH, but they are only one of the biomarkers being examined,
why then are not all biomarkers listed that are processed in the text. I suggest to
use: "Fatty liver, probiotic, biomarkers"
4. The link for the Clinical Trials Registry is not as it should be (cannot be
opened) - suggestion to the authors to correct (the bracket at the end of the link
seems to make it impossible)
5. Throughout the text the unit of measurement after the numbers / letters should
be separated by a space (eg IQR 2.0years should be IQR 2.0 years; HbA1c
<86mmol / mol should be HbA1c <86 mmol / mol)
6. Abbreviations of the Ethics Committee and places of preparation must be in
full title (NRES Committee South Central; Diabetes Center, QAH).
7. The abbreviation SIBO (p.7) is: Small Intestine Bacterial Overgrowth, not
"small bowel bacterial overgrowth". Also the abbreviation HOME-IR (p.8) is not
described It should be written: "HOMA-IR (Homeostatic Model Assessment for
Insulin Resistance)"
8. "400mcg sublingual glycerol trinitrate" - The unit of measurement "mcg" is
not in the SI system - it should be written in ug (micrograms)
9. I suggest that the sentence on p. 8: "... after the administration of after the
administration of 400mcg sublingual glycerol trinitrate
(GTN; an endothelium-independent vasodilator). se pruredi u ".... after the
administration of 400 ug sublingual glycerol trinitrate
(GTN) an endothelium-independent vasodilator. Furthermore, this is
unnecessarily repeated in the next sentence.
10. It is not clear why the CV data ("The coefficient of variation (CV) of these
markers was <10%) is important at the end of each biomarker. Is it the control
variation data for each biomarker or the results obtained. this information is
confusing and unnecessary.
11. I am not an expert in statistics, so I am not able to comment on the choice of
programs and / or statistical methods in my work, although the results are clear
to me.
12. Optional my thinking, given that the study and respondents completed in
early 2014, and the limitation of the study is the relatively small number of
respondents, it may have been possible to collect a larger number of respondents
in this period. However there is again a statistical part that should tell about the
strength of the study.
ADDITIONAL REQUESTS/SUGGESTIONS: 
I wrote all my questions and suggestions in the previous point
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No
Are the methods appropriate and well described?
If not, please specify what is required in your comments to the authors.
Yes
Does the work include the necessary controls?
If not, please specify which controls are required in your comments to the
authors.
Yes
Are the conclusions drawn adequately supported by the data shown?
If not, please explain in your comments to the authors.
No
Are you able to assess any statistics in the manuscript or would you
recommend an additional statistical review?
If an additional statistical review is recommended, please specify what aspects
require further assessment in your comments to the editors.
I recommend additional statistical review
Quality of written English
Please indicate the quality of language in the manuscript:
Acceptable
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