Colonisation Efficacy of a Probiotic Chewing Gum.

BLIS Technologies

Status: Enrolling

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes); Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624177

BLTCT2022/7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes

Active Comparator group

Description:

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.

Treatment:

Dietary Supplement: 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 10 minutes

Active Comparator group

Description:

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.

Treatment:

Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)