L. Brevis CD2 Strain Persistence in Oral Cavity

Overview

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.

Full Title of Study: “Assessment of Probiotic Lactobacillus Brevis CD2 Strain Persistence in Oral Cavity. A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

Interventions

  • Dietary Supplement: L. brevis

Arms, Groups and Cohorts

  • Experimental: L. brevis

Clinical Trial Outcome Measures

Primary Measures

  • Quantification and persistency of Lactobacillus brevis CD2 after oral administration
    • Time Frame: 4 days
    • Mucosal surface colonization in various mouth sites will be assessed by measuring the number of bacteria by Real Time PCR. Quantities of L. brevis DNA will be compared to the total number of bacteria present in the samples.

Secondary Measures

  • Arginine deiminase activity
    • Time Frame: 4 days
    • Enzyme activity, measured as the amount of citrulline formed per minute in the assay conditions, will be determined in saliva samples by HPLC measurements.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Roma La Sapienza
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luciana Mosca, PhD, Principal Investigator – University of Roma La Sapienza

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