L. Brevis CD2 Strain Persistence in Oral Cavity

NCT01782079 | Completed

• 1 other identifier: LB - 001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Keywords

Lactobacillus brevis; Oral health; Bacterial adhesion

Outcome Measures

Primary Outcomes (1)

• Quantification and persistency of Lactobacillus brevis CD2 after oral administration

  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 Outcomes (1)

• Arginine deiminase activity

  4 days

Study Arms (1)

L. brevis

EXPERIMENTAL

Dietary Supplement: L. brevis

Interventions

L. brevis DIETARY_SUPPLEMENT

L. brevis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Healthy subjects with no oral cavity pathologies
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Università La Sapienza

Roma, 00185, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: February 1, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

IT (1)