Role of Lactobacillus reuteri DSM 17938 on Crying Time Reduction in Infantile Colic and Its Impact on Maternal Depression: A Real-Life Clinic-Based Study

Round 1

Reviewer 1 Report

The manuscript 'Role of Lactobacillus reuteri DSM 17938 on crying time reduction in infantile colic: A real-life clinic-based study' is interesting to readers. Systematic reviews have highlighted this role, and this study showed robust evidence on this topic.
See the recent review published: Dos Reis Buzzo Zermiani AP, et al. Evidence of Lactobacillus reuteri to reduce colic in breastfed babies: Systematic review and meta-analysis. Complement Ther Med. 2021 Oct 7; 63:102781. doi: 10.1016/j.ctim.2021.102781. 
I believe that the best news of the present study is the reduction of mother depression (even though they are secondary outcomes (Editado)Restaurar original)! Thus, the authors should improve the title. 

Abstract: Line 21: just new mothers? I believe all mothers have this problem.
Line 29: Give the confidence interval at baseline to 79.1 min at study end.

Materials & Methods: Some characteristics were not reported in this section. Please, describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection.
Why was not the sampling power mentioned? I emphasize that the number of patients can be considered the ideal from a statistical point of view. It would be very interesting if the authors calculated the statistical power of the sample. See http://www.openepi.com/SampleSize/SSMean.htm.

Discussion: should be improved. See the meta-analysis cited above.

Author Response

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Author Response File: Author Response.docx

Reviewer 2 Report

The authors have investigated the effect of L. reuteri on reducing infantile colic by a prospective observational study. The participants in this study showed reduction in crying time, however, as the authors mentioned in discussion, it is known that colic is a self-improving condition and its reduction does not always explains the efficacy of the probiotics. The reviewer recommend the authors to compare the results with other studies on duration of infantile colic by age, or to compare and show the similarity with other studies with controls. 
From above reason, the conclusion " L. reuteri was associated with a significant reduction in crying...." is not adequate. Please consider correcting the conclusion.

Author Response

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Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

The authors have compared the results with previous studies and states that present study has shown the same result, since the results were similar. However, comparison with other studies from different population is not adequate. The authors can only mention about comparison between before and after L.reuteri administration. Hence, the reviewer suggest the authors to conclude such as "The patients received L. reuteri DSM 17938 in this study has shown significant reduction in crying time in colicky infants over the period, which might be associated with improvement in maternal depression."

Author Response

Query: The authors have compared the results with previous studies and states that present study has shown the same result, since the results were similar. However, comparison with other studies from different population is not adequate. The authors can only mention about comparison between before and after L.reuteri administration. Hence, the reviewer suggest the authors to conclude such as "The patients received L. reuteri DSM 17938 in this study has shown significant reduction in crying time in colicky infants over the period, which might be associated with improvement in maternal depression."

 

Response: Conclusion revised to "This study observed that colicky infants who received L. reuteri DSM 17938 showed significant reduction in crying time in over the period, which might be associated with improvement in maternal depression".