L. Brevis CD2 Strain Persistence in Oral Cavity
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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 |
- 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.
- 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 |
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 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 May 23, 2013