Levilactobacillus Brevis Oral Health (LBOH-RCT)

Randomized Controlled Trial on the Effect of Levilactobacillus Brevis (CNCM I-5566) Probiotic Supplement on Clinical and Salivary Oral Indicators

This RCT investigates the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. Participants will be randomly assigned to either the probiotic supplement group or a placebo group. The primary objective is to assess changes in salivary biomarkers, including salivary pH and buffer capacity; microbial composition using microbiome next-generation sequencing (NGS); and clinical oral inflammatory markers, such as full mouth bleeding score and full mouth plaque score, over a 4-week period. By comparing these indicators between the two groups, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566 in promoting oral health and potentially preventing oral diseases.

Study Overview

• Status: Completed
• Conditions: Oral Disease; Oral Health
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Levilactobacillus brevis CNCM I-5566

Detailed Description

This RCT is designed to investigate the impact of an oral supplement containing the probiotic Levilactobacillus brevis CNCM I-5566 on various salivary indicators of oral health. The study aims to provide robust evidence on the efficacy of this probiotic in promoting oral health and potentially preventing oral diseases.

Study Design:

Participants will be randomly assigned to one of two groups: the experimental group, which will receive the Levilactobacillus brevis CNCM I-5566 probiotic supplement, and the control group, which will receive a placebo. This random assignment ensures that the groups are comparable at the start of the trial, allowing for unbiased comparison of outcomes.

Duration:

The study will be conducted over a 4-week treatment period, during which participants will adhere to their assigned supplement regimen.

Primary Objectives:

The primary objective of this RCT is to assess the impact of Levilactobacillus brevis CNCM I-5566 on several key indicators of oral health, measured through salivary biomarkers, microbial composition, and clinical oral inflammatory markers.

Salivary Biomarkers:

Salivary pH: The acidity or alkalinity of saliva, which can influence oral health by affecting the growth of bacteria and the integrity of tooth enamel.

Buffer Capacity: The ability of saliva to neutralize acids, which is crucial for maintaining a healthy oral environment and preventing dental caries.

Salivation rate: The amount of salivary production (mL) overtime (in 5 minutes). This parameter is needed for individual caries risk assessment.

Microbial Composition:

The composition of the oral microbiome will be analyzed using next-generation sequencing (NGS). This advanced technique allows for a comprehensive assessment of the microbial populations present in the saliva and dental plaque, providing insights into how the probiotic supplement may alter the microbiome to support oral health.

Clinical Oral Inflammatory Markers:

Full Mouth Bleeding Score: A measure of gum inflammation and bleeding, which are indicators of gingivitis or periodontal disease.

Full Mouth Plaque Score: A measure of the accumulation of dental plaque, which is a biofilm of bacteria that can lead to tooth decay and gum disease if not properly managed.

Outcome Comparison:

By comparing the changes in these indicators between the probiotic supplement group and the placebo group, the study aims to determine the efficacy of Levilactobacillus brevis CNCM I-5566. Significant improvements in the probiotic group compared to the placebo group would suggest that Levilactobacillus brevis CNCM I-5566 is effective in promoting oral health and preventing oral diseases.

Significance:

This study has the potential to contribute valuable information to the field of oral health, particularly in understanding how probiotics can be used as a preventive measure against oral diseases. If successful, the findings could lead to new recommendations for probiotic use in dental care routines.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • IT
    • L'Aquila, IT, Italy, 67100
      • University of L'Aquila

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers of both sexes.
• Dental caries experience (DMFT) less than 4.

Exclusion Criteria:

• Active or historical periodontitis.
• Diabetes mellitus diagnosis.
• Active or historical cancer diagnosis.
• Antibiotic therapy within the past 3 months.
• Currently undergoing active therapy with drugs.
• Presence of disabilities affecting the ability to maintain oral hygiene at home.
• Recent professional oral hygiene treatment within the last 3 months.
• Pregnancy.
• Presence of eating disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Participants will take four placebo tablets daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner.
Experimental: L. brevis	Dietary supplement: Levilactobacillus brevis CNCM I-5566; Participants will take four Mucomixx tablets (containing Levilactobacillus brevis CNCM I-5566) daily for 28 days. The tablets should be taken after each of the following meals: breakfast, lunch, afternoon break, and dinner.; Other Names: Mucomixx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary pH	Assay used to define dental caries risk	Baseline, 4 and 6 weeks
Full mouth bleeding score	Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score)	Baseline, 4 and 6 weeks
Full mouth plauqe score	Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score)	Baseline, 4 and 6 weeks

Collaborators and Investigators

• Sponsor: University of L'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases
• Other Study ID Numbers: 48/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No