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L. Brevis CD2 Strain Persistence in Oral Cavity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luciana Mosca, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01782079
First received: January 18, 2013
Last updated: March 22, 2013
Last verified: March 2013

January 18, 2013
March 22, 2013
January 2013
March 2013   (final data collection date for primary outcome measure)
Quantification and persistency of Lactobacillus brevis CD2 after oral administration [ Time Frame: 4 days ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01782079 on ClinicalTrials.gov Archive Site
Arginine deiminase activity [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Enzyme activity, measured as the amount of citrulline formed per minute in the assay conditions, will be determined in saliva samples by HPLC measurements.
Same as current
Not Provided
Not Provided
 
L. Brevis CD2 Strain Persistence in Oral Cavity
Assessment of Probiotic Lactobacillus Brevis CD2 Strain Persistence in Oral Cavity. A Pilot Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Oral Health
Dietary Supplement: L. brevis
Experimental: L. brevis
Intervention: Dietary Supplement: L. brevis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01782079
LB - 001
No
Luciana Mosca, PhD, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Not Provided
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP