Microbial Colonization of Oral Probiotics

BLIS Technologies

Status: Unknown

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotics A and B; Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic B; Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic A; Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic B; Dietary Supplement: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B; Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic A; Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotics A and B; Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic A; Dietary Supplement: Probiotic S. salivarius K12 powder; Dietary Supplement: Probiotic S. salivarius M18 lozenges; Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic B; Dietary Supplement: Streptococcus salivarius K12 lozenge

Study type: Interventional

Funder types: Industry

Identifiers

NCT05375383

BLTCT2022/3

Details and patient eligibility

About

The aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics 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 lozenges and powders containing two different commercially available probiotic bacteria (S. salivarius K12 ) or S. salivarius M18 with or without 2 different prebiotic sugars or their combinations.

Participants will be randomly assigned to one of the 12 groups consuming probiotic lozenge or powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity) over a seven day period. Saliva samples will be collected at predetermined time points pre and post intervention. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female 18y - 80y age
2. In general good health 18 - 80 years of age.
3. 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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60 participants in 12 patient groups

Streptococcus salivarius K12 lozenge

Active Comparator group

Description:

Streptococcus salivarius K12 lozenge

Treatment:

Dietary Supplement: Streptococcus salivarius K12 lozenge

Probiotic S. salivarius K12 lozenges containing prebiotic A

Active Comparator group

Description:

Streptococcus salivarius K12 lozenge with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic A

Probiotic S. salivarius K12 lozenges containing prebiotic B

Active Comparator group

Description:

Streptococcus salivarius K12 lozenge with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotic B

Probiotic S. salivarius K12 lozenges containing prebiotic A and B

Active Comparator group

Description:

Streptococcus salivarius K12

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 lozenges containing prebiotics A and B

Probiotic S. salivarius K12 powder

Active Comparator group

Description:

Streptococcus salivarius K12 powder

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 powder

Probiotic S. salivarius K12 powder containing prebiotic A

Active Comparator group

Description:

Streptococcus salivarius K12 powder with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic A

Probiotic S. salivarius K12 powder containing prebiotic B

Active Comparator group

Description:

Streptococcus salivarius K12 powder with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotic B

Probiotic S. salivarius K12 powder containing prebiotic A and B

Active Comparator group

Description:

Streptococcus salivarius K12 powder with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius K12 powder containing prebiotics A and B

Probiotic S. salivarius M18 lozenges

Active Comparator group

Description:

Streptococcus salivarius M18 lozenge

Treatment:

Dietary Supplement: Probiotic S. salivarius M18 lozenges

Probiotic S. salivarius M18 lozenges containing prebiotic A

Active Comparator group

Description:

Streptococcus salivarius M18 lozenge with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic A

Probiotic S. salivarius M18 lozenges der containing prebiotic B

Active Comparator group

Description:

Streptococcus salivarius M18 lozenge with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius M18 lozenges containing prebiotic B

Probiotic S. salivarius M18 + lozenges containing prebiotic A and B

Active Comparator group

Description:

Streptococcus salivarius M18 lozenge with prebiotic

Treatment:

Dietary Supplement: Probiotic S. salivarius M18 + lozenges containing prebiotic A and B