Levilactobacillus Brevis Oral Health

NCT06457724 | Completed

• 1 other identifier: 48/2022
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Health; Oral Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

L. brevis

EXPERIMENTAL

Dietary Supplement: Levilactobacillus brevis CNCM I-5566

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Levilactobacillus brevis CNCM I-5566 DIETARY_SUPPLEMENT

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.

Also known as: Mucomixx

L. brevis

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

University of L'Aquila

L’Aquila, IT, 67100, Italy

Location

Related Publications (1)

• Altamura S, Lombardi F, Augello FR, Barone A, Giannoni M, Cinque B, Pietropaoli D. Levilactobacillus brevis CD2 as a multifaceted probiotic to preserve oral health: results of a double-blind, randomized, placebo-controlled trial in healthy adults. J Transl Med. 2025 Jan 28;23(1):128. doi: 10.1186/s12967-024-06000-1.

  PMID: 39875908 DERIVED

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: October 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)