1- Which scientific committee reviewed the protocol?
2-Funding amount is in what currency?
3- Employees may be considered a vulnerable group, vulnerable to coercion. Please explain how the investigator will avoid coercion in the population of employees.
4- Study population: please justify the use of this population.
5- Criteria for discontinuation should mention that participants could be withdrawn if they do no want to continue participation.
6-Methodology: The methodology is not clear.
a-What are the 4 bacteria that will be tested?
b-Why culture the stool, while PCR could be done directly on the stool?
c-The chart does not mention stool collection.
d-The chart mentions 2 groups according to diet and depression, then 4 groups according to depression. Please explain how many groups will be available at the end?
e- What are the criteria for the nutritional groups?
f-We need to review the questionnaires used in the study
g- The co-investigators do not include a psychologist or psychiatrist for the review depression part.
h-Who decided about the depression questionnaire to be used?
i- What is the statistical analysis plan?
7- Statistics: Was the number of groups included in the sample size calculation?
8- What are the benefits of the study? These should be mentioned.
9-Informed Consent:
a- Needs revision of the Arabic language. For example: قد تم تعاني
and others
b- The consent mentions that the participants may have depression, on which basis? The protocol mentions normal employees!
c- Consent mentions 4 groups according to nutrition, while the chart mentions 4 groups according to depression status.