L. Brevis CD2 Strain Persistence in Oral Cavity

Assessment of Probiotic Lactobacillus Brevis CD2 Strain Persistence in Oral Cavity. A Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01782079

Enrollment

Registered

2013-02-01

Start date

2013-01-31

Completion date

2013-03-31

Last updated

2013-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Keywords

Lactobacillus brevis, Oral health, Bacterial adhesion

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.

Interventions

DIETARY_SUPPLEMENTL. brevis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026