Clinical Trials Directory

Trials / Completed

CompletedNCT01782079

L. Brevis CD2 Strain Persistence in Oral Cavity

Assessment of Probiotic Lactobacillus Brevis CD2 Strain Persistence in Oral Cavity. A Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of Roma La Sapienza · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTL. brevis

Timeline

Start date
2013-01-01
Primary completion
2013-03-01
Completion
2013-03-01
First posted
2013-02-01
Last updated
2013-03-25

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01782079. Inclusion in this directory is not an endorsement.