Levilactobacillus Brevis Oral Health (LBOH-RCT)

July 3, 2024 updated by: Davide Pietropaoli, University of L'Aquila

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Salivary pH
Time Frame: Baseline, 4 and 6 weeks
Assay used to define dental caries risk
Baseline, 4 and 6 weeks
Full mouth bleeding score
Time Frame: Baseline, 4 and 6 weeks
Index used to quantify gingival inflammation (Percentage as Full mouth Bleeding score)
Baseline, 4 and 6 weeks
Full mouth plauqe score
Time Frame: Baseline, 4 and 6 weeks
Index used to quantify individual capacity to home oral health (Percentage as Full mouth Plaque score)
Baseline, 4 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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