National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Innovative synbiotic yogurt balancing immediate probiotic support and long-term safe prebiotic delivery using PLGA nanoparticles

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

- Research Team Information: 2Co-Investigator: Bahgat Fayed: Affiliation, Written: Department of Chemistry of Natural and Microbial Products Pharmaceutical and Drug Industries research institute. While in Form 90, written Dairy Department Food Industries and Nutrition Research Institute. 

- Procedure in Details: Safety study: Animals: Written, Wistar male rats (12) that weighed 170-200g will be used in the current work (20 for toxicological study and 15 for safety study). The number of the animal (12) is wrong. The correct is 35.

- Procedure in Details: You did not mention anything about yogurt making. Although this is an essential part of the study.

- Gantt and Flowcharts: The two are the same.

- Application for Research Studies Involving Animals: Total Number: written 12. It is wrong. The correct is 35.

- Dose your study involves collection of biological samples: You written No. Although, You mention blood samples will be collected. And The liver, kidney, heart, lungs, spleen, brain and testis will be carefully dissected out, and weighed.

- There is a repetition of the part of the animal study in more one place.

- Department and institutional approval: 90.pdf: Form 90 attach without the adoption of head of the Department, Dean of the Institute, and the competent Committee.

- You did not mention something about Safety.   

Comment to the Committee

Informed consent form:

N/A

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