L. Brevis CD2 Strain Persistence in Oral Cavity

Not Applicable

Completed

• Conditions: Oral Health
• Interventions: Dietary Supplement: L. brevis

• Registration Number: NCT01782079
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-22
• Last Update Posted: 2013-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L. brevis	L. brevis	-

Primary Outcome Measures

Name	Time	Method
Quantification and persistency of Lactobacillus brevis CD2 after oral administration	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

Name	Time	Method
Arginine deiminase activity	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.

Trial Locations

Locations (1)

Università La Sapienza; 🇮🇹 Roma, Italy