2.3. Blinding
BLIND
The identity of probiotic and control treatments will not be known to investigators, research staff, or subjects. The following study procedures will be in place to ensure double-blind administration of study treatments:Access to the randomization code will be strictly controlled.Packaging and labeling of test and control treatments were coded, but shape, color, smell, and weight will be identical.Due to necessity of evaluate the activity of treatment product, both packages (with different letters) will be sent to microbiology lab to determine the activity of strains, the result will be blind without mention to any letter.Unblinding will be done on completion of the clinical study. During the study, the blind may be broken only in emergencies when knowledge of the subject treatment group is necessary for further subject management. In this case, the investigator should discuss the emergency with the Medical Monitor prior to unblinding. The principal investigator (PI) has a direct number-mobile to contact with the company personnel in charge of blinding. The product will be provided in sachets packed and coded as numbers. All subjects will be allocated in blocks according to their gender, age, and BMI. From those blocks, PI will make a list of pairs, each pair has 2 subjects. This list will be sent later to the collaborative members from inpatient pharmacy, who will allocate subjects (1:1) in 2 different groups. The randomization scheme will be computer generated using Excel sheet. After completing the intervention, a request letter will be sent to the company to unblind the study. Then the company lab will send an unblinding letter to inform us which alphabet is probiotic or placebo.