Production and investigation of antibacterial effects of chewing gum containing postbiotic yeast Saccharomyces boulardi and its chewing effect on Streptococcus mutans levels in human saliva: a randomized controlled trial

The purpose of this study is to investigate the effect of postbiotic consumption of Saccharomyces boulardi on the number of Streptococcus mutans bacteria in the mouth.

Clinical trial including three groups of participants with a parallel design, three blind strains, randomized, phase three on 90 people. Sealed envelope lottery will be used for randomization.

The participants will be selected from among the staff of resaerch deputy of Alborz University of Medical Sciences and their families. The saliva sample of the eligible people is collected and then according to the person's lottery, they are placed in one of the test groups, and the chewing gum with the selected code will be provided to the person in the amount necessary for consumption for ten days. Then the person will use this gum twice a day for ten days. The gums of the three groups have the same appearance and none of the participants, researchers and the person who performs the statistical analysis work will know the assignment of people to the groups. After ten days, saliva samples will be collected and the number of Streptococcus mutans bacteria in the saliva samples will be counted and compared in three groups.

All people aged 15 to 40 who do not have active oral disease and are not allergic to gum compounds and have not used food products containing probiotics during the two weeks prior to the study can enter the study.

This study will have three groups of participants. A group of regular chewing gum, a group of chewing gum containing postbiotics, and a group of chewing gum containing xylitol who will consume it twice a day for 20 to 30 minutes for ten days.

Streptococcus mutans bacteria count in saliva

Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes.

In this study, the gums of all three groups are similar to each other and only the code assigned to them is different. Participants, clinical examiners, researchers, and laboratory personnel who have access to the collected samples and data, as well as the person performing the statistical analysis will be blinded to the coding of the groups until the disclosure of the codes after statistical analysis.

After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant.

Access starts 6 months after results are published

All researchers working in academic and scientific institutions and people working in the industry

If a request with this theme is received, a decision will be made with the opinion of the research team.

From the project manager, Dr. Hadi Pourjafar

After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant.