NCT05624177

Colonisation Efficacy of a Probiotic Chewing Gum.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: BLIS Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

Detailed description

This is a single blind, randomized controlled study to evaluate the colonization effectiveness of a chewing gum containing a commercially available probiotic bacterium. Participants will be randomly assigned to one of the two groups consuming chewing gum containing Streptococcus salivarius M18 over a 7-day period. Saliva samples will be collected at pre determined points (pre and post intervention). Colonization efficacy will be determined by enumerating the probiotic from the saliva samples using standard microbiological techniques.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)	Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.
DIETARY_SUPPLEMENT	Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)	Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-01-01
• Completion: 2023-03-01
• First posted: 2022-11-22
• Last updated: 2022-11-23

Locations

1 site across 1 country: New Zealand