National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

The efficiency of yeast isolated from manuka honey as a probiotic agent and study of its role in weight control

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

- Protocol Title in English and in Arabic: incorrect, whereas the work will be using Yeast extract (not alive) and Levan extract. In this case it be prebiotic. Also Levan not found in the Title. So, I suggest changing the title to be:

The efficiency of yeast and levan isolated from manuka honey as a prebiotic agent and study of its role in weight control of rats.

كفاءة إستخدام الخميرة والليفان المعزولين من عسل المانوكا كعامل بريبيوتيك ودراسة دورها في التحكم فى وزن الفئران

- Duration of the study: Written 9 weeks. Whereas, written in Gantt-chart 11 weeks.

- Fund amount: written Self. Don't write an amount.

- Keywords: Correct a word probiotic to be prebiotic. And Add a word levan.

- Research Team Information: 1Co-Investigator: Written Principal Investigator.

- In all Co-Investigator: The Department and Institute are not written.

- Secondary Objectives: Written many levans were found to act as probiotics. This is a mistake, it acts as prebiotics.

- Procedure in Details: Animals: Written fifty-three. While, written afterwards five groups of seven animals each (So the number is 35). And in Application for Research Studies Involving Animals: Total Number: written 35.

- Also, written in Procedure in Details: Animals: female Wistar rats. Why would you use females and not males? Although it is preferable to use males.

- Written the animals will be access to distilled water. Why use distilled water instead of using tap water?

- Written in Procedure in Details and in Secondary Objectives: Will be isolation and production Both yeast and levan. And it will be used yeast extract. However, it was not written (Yeast name - How to isolate the yeast - How to produce yeast - How to extract levan - How the yeast and levan extracts work.

- Does this protocol involve the use of substances that may pose any health risk: Written No. How, blood samples will be taken - taking internal organs - microbiology working - Use of chemicals (solvents).

- Application for Research Studies Involving Animals: Sex:  Written Female (Why use females?). And no males were used.

- Reproductive Status Female: Mature-female.

Total Number: 35

- Dose your study involves collection of biological samples: Sample: Written blood (only). Although it is written in the internal organs (heart, liver, kidneys, spleen, brain, and pancreas) will be taken.        

- What is the expected severity of pain the animal will suffer in your study: Written No pain. How, the rats daily orally administered the treatments using a stomach tube for 4 weeks. And will be weighed daily for the same period.

- Describe how pain or distress will be monitored: Written Not applicable. How ?.

- فى نموذج اقرار التعامل مع الحيوانات: سؤال هل تتوقع حدوث أعراض جانبية مثل ألم أو أذى أو معاناة للحيوان: مكتوب لا يوجد (كيف) وانة سوف يتم تجريع الحيوانات عن طريق الفم باستخدام انبوبة المعدة يوميا ولمدة 4 أسابيع. وكذلك وزن الحيوانات يوميا ولنفس المدة.

- سؤال: كيف سيتم التعامل معها أو محاولة تجنبها أو تخفيفها: مكتوب لا يوجد (كيف).

Comment to the Committee

Informed consent form:

N/A

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