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L. Brevis CD2 Strain Persistence in Oral Cavity

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ClinicalTrials.gov Identifier: NCT01782079
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : March 25, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Oral Health Dietary Supplement: L. brevis

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of Probiotic Lactobacillus Brevis CD2 Strain Persistence in Oral Cavity. A Pilot Study
Study Start Date : January 2013
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: L. brevis Dietary Supplement: L. brevis

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782079

Università La Sapienza
Roma, Italy, 00185
Sponsors and Collaborators
University of Roma La Sapienza
More Information

Responsible Party: Luciana Mosca, PhD, Principal Investigator, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01782079     History of Changes
Other Study ID Numbers: LB - 001
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: March 2013

Keywords provided by Luciana Mosca, PhD, University of Roma La Sapienza:
Lactobacillus brevis
Oral health
Bacterial adhesion