Microbial Colonization of Dairy Free Oral Probiotics

John Hale

Status: Unknown

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Streptococcus salivarius M18 dairy free lozenges; Dietary Supplement: Streptococcus salivarius M18 lozenges

Study type: Interventional

Funder types: Industry

Identifiers

NCT05375396

BLTCT2022/4

Details and patient eligibility

About

The aim of this study is to evaluate the colonization efficacy of probiotic lozenges containing dairy and dairy free probiotic Streptococcus salivarius M18, in healthy adults

Full description

This is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of two different lozenges containing either dairy or dairy free probiotic bacteria Streptococcus salivarius M18.

Participants will be randomly assigned to one of the 2 groups consuming probiotic lozenge containing dairy free Streptococcus salivarius M18 or dairy based Streptococcus salivarius M18 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Male or Female 18y - 80y age

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Streptococcus salivarius M18 lozenges

Active Comparator group

Description:

Streptococcus salivarius M18 lozenges containing dairy based Streptococcus salivarius M18

Treatment:

Dietary Supplement: Streptococcus salivarius M18 lozenges

Streptococcus salivarius M18 dairy free lozenges

Active Comparator group

Description:

Streptococcus salivarius M18 lozenges containing dairy free Streptococcus salivarius M18

Treatment:

Dietary Supplement: Streptococcus salivarius M18 dairy free lozenges