L. Brevis CD2 Strain Persistence in Oral Cavity

University of Roma La Sapienza

Status: Completed

Conditions: Oral Health

Treatments: Dietary Supplement: L. brevis

Study type: Interventional

Funder types: Other

Identifiers

NCT01782079

LB - 001

Details and patient eligibility

About

The aim of this study is to select the optimal conditions for quantification in the oral cavity of Lactobacillus brevis CD2, a probiotic strain contained in a commercially available dietary supplement and to assess its persistency after oral administration. Different sets of primers for L. brevis detection will be tested in real-time PCR reactions to find optimal amplification efficiency and target specificity. Primers ability in the identification of L. brevis DNA will be assessed in a pilot study conducted on 12 healthy volunteers clinically free of oral pathologies. The subjects will take 3 tablets/day for 3 days and one tablet on the 4th day. Clinical samples (dorsal surface of tongue, first molar, vestibular fornix and saliva) will be collected at baseline (before beginning the trial), at T0 (in the morning before the assumption of the last tablet) and 3, 6, and 9 hours after taking the last tablet. The quantities of L. brevis DNA will be compared to the total number of bacteria present in the samples. The activity of the enzyme arginine deiminase, responsible for oral pH homeostasis (particularly abundant in the CD2 strain) will be also assessed in the saliva samples before and after treatment, by HPLC measurements.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Healthy subjects with no oral cavity pathologies
• Written informed consent

Exclusion criteria

• Patients with oral diseases
• Patients with systemic diseases
• Celiac patients or subjects affected by allergic reactions to soy proteins
• Use of antibiotics or other probiotics

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

L. brevis

Experimental group

Treatment:

Dietary Supplement: L. brevis