Double-blind Clinical Trials of Probiotic Products in Oral Health.

glac Biotech

Status: Completed

Conditions: Probiotic Metabolites; Oral Health; Probiotics

Treatments: Dietary Supplement: Combined probiotics (2); Dietary Supplement: Combined heat-killed probiotics (1); Dietary Supplement: Probiotic metabolites; Dietary Supplement: Combined probiotics (1); Dietary Supplement: Combined heat-killed probiotics (2); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04289337

CS19052

Details and patient eligibility

About

In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.

Enrollment: 130 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults between 20 to 40 years old.
• More than 10^5 Streptococcus mutans (CFU/mL) of saliva.

Exclusion criteria

• Smoking.
• Subject has major illness.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 6 patient groups, including a placebo group

Combined probiotics (1)

Experimental group

Description:

Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.

Treatment:

Dietary Supplement: Combined probiotics (1)

Combined probiotics (2)

Experimental group

Description:

Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66.

Treatment:

Dietary Supplement: Combined probiotics (2)

Combined heat-killed probiotics (1)

Experimental group

Description:

Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.

Treatment:

Dietary Supplement: Combined heat-killed probiotics (1)

Combined heat-killed probiotics (2)

Experimental group

Description:

Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66.

Treatment:

Dietary Supplement: Combined heat-killed probiotics (2)

Probiotic metabolites

Experimental group

Description:

Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites.

Treatment:

Dietary Supplement: Probiotic metabolites

Placebo

Placebo Comparator group

Description:

Does not contain probiotics, heat-killed probiotics and related metabolites.

Treatment:

Dietary Supplement: Placebo