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ClinicalTrials.gov Identifier: NCT01782079
: February 1, 2013
Last Update Posted
: March 25, 2013
University of Roma La Sapienza
Information provided by (Responsible Party):
Luciana Mosca, PhD, University of Roma La Sapienza
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.
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 Outcome 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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age > 18 years
Healthy subjects with no oral cavity pathologies
Written informed consent
Patients with oral diseases
Patients with systemic diseases
Celiac patients or subjects affected by allergic reactions to soy proteins