Colonisation Efficacy of Oral Probiotic Fast Melt Powder

Not Applicable

• Conditions: Microbial Colonization
• Interventions: Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g); Dietary Supplement: Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)

• Registration Number: NCT05367518
• Lead Sponsor: BLIS Technologies Limited

Brief Summary

To evaluate the colonisation efficacy (i.e. ability of the probiotic bacteria to remain in your mouth) of a fast melt powder that quickly dissolves in the mouth. The fast melt powder will contain a Streptococcus salivarius probiotic and the study is to be done in healthy adults.

Detailed Description

This is a double-blind, randomized controlled study with no cross over to evaluate the colonization efficacy of fast melt powders containing a commercially available probiotic bacterium Streptococcus salivarius K12.

Participants will be randomly assigned to one of the 2 groups consuming Fast Melt powder containing two different doses of Streptococcus salivarius K12 over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Study First Posted: 2022-05-10
• Last Update Posted: 2022-05-10
• Study Start: 2022-05-15
• Primary Completion: 2022-05-25
• Study Completion: 2022-06-30

Recruitment & Eligibility

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

Inclusion Criteria

1. In general good health 18 - 80 years of age.
2. Practice good oral hygiene.

Exclusion Criteria

1. Have a history of autoimmune disease or are immunocompromised.
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g	Probiotic Streptococcus salivarius K12 Fast Melt Powder 1 Billion colony forming units /g)	Probiotic Streptococcus salivarius K12 Fast Melt Powder (Dose 1: 1 Billion colony forming units /g)
Streptococcus salivarius K12 Fast Melt Powder 100 million colony forming units /g	Probiotic Streptococcus salivarius K12 Fast Melt Powder 100 Million colony forming units /g)	Group B: Dose 2 Streptococcus salivarius K12 Fast Melt Powder (Dose 2: 100 Million colony forming unit/gram)

Primary Outcome Measures

Name	Time	Method
Change in microbial colonization from baseline (Day 0) to 1 hour	1 hours post intervention	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to one hour after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
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 two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 8 hours after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Change in microbial colonization from baseline (Day 0) to 24 hours	24 hours post intervention	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 24 hours after later across two different formulations with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).
Change in microbial colonization from baseline (Day 0) to 48 hours post last dose	48 hours after last dosing following 7 days of daily administration of probiotic	Study will determine the change in microbial colonization efficacy of two different doses of Streptococcus salivarius K12 in a fast melt powder format. The saliva Statistical analysis (e.g. Students t-test) will be carried out to compare the participants data from baseline to 48 hours after last dosing across two different formulations over 7 days, with the level of significance of p≤0.05.Overall colonization based on percentage of population colonized for different interventions will also be analyzed average and standard deviation functions using appropriate statistical analysis software (e.g. Microsoft Excel).

Trial Locations

Locations (1)

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