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
  Purpose

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 Intervention
Oral Health
Dietary Supplement: L. brevis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of Probiotic Lactobacillus Brevis CD2 Strain Persistence in Oral Cavity. A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L. brevis Dietary Supplement: L. brevis

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782079

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

No publications provided

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
Study First Received: January 18, 2013
Last Updated: March 22, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Lactobacillus brevis
Oral health
Bacterial adhesion

ClinicalTrials.gov processed this record on October 23, 2014