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Study Protocol
Peer-Review Record

Bicarbonate Natural Mineral Water from Source “F2 Păltiniș” Facilitates Digestion—A Pilot Study

Gastrointest. Disord. 2025, 7(3), 47; https://doi.org/10.3390/gidisord7030047
by Fabio Pace 1,*, Antonio Maria Morselli-Labate 2,*, Aladin Abu Issa 1,* and Alessandro Zanasi 3,*
Reviewer 1:
Reviewer 2: Anonymous
Gastrointest. Disord. 2025, 7(3), 47; https://doi.org/10.3390/gidisord7030047
Submission received: 15 April 2025 / Revised: 7 July 2025 / Accepted: 8 July 2025 / Published: 11 July 2025

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

 

The study is interesting. However, I have some comments about the manuscript:

  1. Keywords are missing.
  2. A paragraph for abbreviations should be added following the discussion section to list and explain abbreviations used in the study. This addition is intended to improve readability and ensure all terms are clearly understood.
  3. P values used for statistical descriptions throughout the article should be italicized.
  4. The abstract is written in a complex way, and readers can easily be confused (the abstract indicates the main findings and most important results). It would be easy to read if it were structured with headers (Background, Objective, Methods, Results, and Conclusions in separate paragraphs).
  5. Please ensure that all references have DOI links.
  6. An additional table of baseline and clinical characteristics of the study population would be helpful (i.e., eligibility criteria, sex, age (years, mean ± SD), body mass index (BMI), bowel movements, other comorbidities (CCI score), outcomes…)).
  7. The authors should perform a flowchart of subject selection (a graphical representation of a process) to illustrate the results of their research and the screening process to enable better reading comprehension.
  8. Factors that could influence the results have not been considered:

The authors should mention whether participants took probiotics, magnesium, and calcium supplements, or the intake of mineral water other than the investigational product during the study.

  1. Different font in several manuscript sections (e.g., Lines 104-105).
  2. Additionally, there is insufficient information regarding the limitations of the study. The study exclusively focuses on Caucasian participants. However, while the focus is on Caucasians, the lack of diversity raises questions about applicability to broader populations. In addition, a discussion on potential biases and plans for external validation in multi-ethnic cohorts would strengthen the work.
  3. Line 119: “age >18 years.” Please change to “Adults ≥18 years.”
  4. A summary of Adverse Events (AEs) or Serious Adverse Events (SAEs) per treatment should be provided (if any).
  5. There is no mention in the manuscript as to how much missing data there is, nor how missing data are handled in the analysis.
  6. Additionally, please present in a separate table the specific mineral content of Aqua Carpatica natural mineral water and tap water (mg/L).

Author Response

Please see the attachment ReviewerResponse.pdf.

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

Informed consent statement and IRSB statement missing – and required.

Methodologically weak. The paper has several biases that limit its validity. First, the use of tap water introduces comparator bias, as it lacks both (!) carbonation and minerals, making it physiologically and perceptually distinct from the test water. The open-label design, combined with no blinding of participants or investigators, increases the likelihood of expectation and observer bias. Additionally, the fixed intervention sequence—with tap water always preceding test water —introduces sequence and carryover bias. The two types of water have a distinct difference in taste, texture, and mouthfeel which probably reinforced perceived treatment effect. The reliance solely on subjective endpoints (RDQ, PGWB-S), without any objective physiological or biochemical measures, further amplifies the susceptibility to placebo effects. The study also lacks randomization, has a small sample size (n=41). This is interesting because the authors state that they needed 45 subjects to give a result, and started off with 44. The term “pair” is incorrect here, since it implies a matched pair or paired design, but since there was no randomization (all received tap water first), this is not applicable. The power calculation specifically assumes a cross over with randomization – which is not the case here.

Overall, while the results are promising, but the design limitations necessitate very cautious interpretation. The paper has the danger of fulfilling a predetermined narrative, without evidence.

Author Response

Please see the attachment ReviewerResponse.pdf.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

The text often lacks clear and concise wording. long sentences and unnecessary language make it difficult to follow. Scientific text should be direct and clear.The repeated use of the product name (“Aqua Carpatica from the F2 PăltiniÈ™ spring”) gives the impression of product promotion rather than objective scientific research. This undermines the neutrality expected in clinical research.There are several weakness in the study.The sample includes only Caucasians individuals, which limits generalizability and raises concerns about demographic bias.

The authors used validated instruments (RDQ, PGWB-S) that are appropriate and well explained, as well as the use of appropriate non-parametric tests (Wilcoxon, McNemar). However, their study has several weaknesses. Their study did not include randomization or placebo control. This limits the ability to draw definitive conclusions or control for placebo effects. However, the lack of blinding (participant or investigator) increases the risk of bias in symptom assessment. The use of tap water as an appropriate control does not represent a valid control condition, as the absence of both placebo control and blinding introduces potential biases and undermines the internal validity of the study. It is not stated how compliance or accuracy of the questionnaire was ensured (e.g., investigator presence, self-completion). It should clearly include a justification of the sample size, the expected effect size, and the assumptions behind the calculation. Meticulous proofreading and adherence to formal academic style are required, as multiple typographical and formatting errors (e.g., "preseStatistical Analysis", "theirhome", "to rereport") detract from clarity and professionalism. There is no mention of ethical approval procedures or informed consent in the materials and methods.

The study requires revision in light of the issues outlined above. Figures and tables could enrich their work.

Comments on the Quality of English Language

The text often lacks clear and concise wording. long sentences and unnecessary language make it difficult to follow. Scientific text should be direct and clear.The repeated use of the product name (“Aqua Carpatica from the F2 PăltiniÈ™ spring”) gives the impression of product promotion rather than objective scientific research. 

 Meticulous proofreading and adherence to formal academic style are required, as multiple typographical and formatting errors (e.g., "preseStatistical Analysis", "theirhome", "to rereport") detract from clarity and professionalism. 

The study requires revision in light of the issues outlined above. Figures and tables could enrich their work.

Author Response

Please see the attachment ReviewerResponse.pdf.

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

Dear authors,

You have adequately addressed my comments in the revised version of the manuscript.

Therefore, I have no further comments.

Author Response

Look at the attached file

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

Accept

Author Response

Look at the attached file

Author Response File: Author Response.pdf

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