- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01782079
L. Brevis CD2 Strain Persistence in Oral Cavity
March 22, 2013 updated by: Luciana Mosca, PhD, University of Roma La Sapienza
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Roma, Italy, 00185
- Università La Sapienza
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: L. brevis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
January 18, 2013
First Submitted That Met QC Criteria
January 30, 2013
First Posted (Estimate)
February 1, 2013
Study Record Updates
Last Update Posted (Estimate)
March 25, 2013
Last Update Submitted That Met QC Criteria
March 22, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- LB - 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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