Colonisation Efficacy of a Probiotic Chewing Gum.

Not Applicable

Recruiting

• Conditions: Microbial Colonization
• Interventions: Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes); Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)

• Registration Number: NCT05624177
• Lead Sponsor: BLIS Technologies Limited

Brief 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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-23
• Study Start: 2022-12
• Primary Completion: 2023-01
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• In general, good health
• Practice good oral hygiene

Exclusion Criteria

• Have a history of autoimmune disease or are immune compromised.
• Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
• People with allergies or sensitivities to dairy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes	Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)	Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.
Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes	Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)	Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.

Primary Outcome Measures

Name	Time	Method
Change in Microbial colonization from baseline (Day 0) to 8 hours.	8 hours post intervention.	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.	8 hours past last dose following 7 days of twice daily administration of probiotic.	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose.	48 hours past last dose following 7 days of twice daily administration of probiotic.	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.
Change in Microbial colonization from baseline (Day 0) to 1 hour.	1 hour post intervention.	Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

Trial Locations

Locations (1)

Blis Technologies Ltd; 🇳🇿 Dunedin, Otago, New Zealand