NCT03540498

Study of Colonization of Strains L.Plantarum and L.Brevis in the Product AB-DENTALAC Chewing Gum

Oral Colonization by Lactobacillus Brevis KABP 052 (CECT 7480) and Lactobacillus Plantarum KABP 051 (CECT 7481): A Randomized, Double-Blinded, Placebo-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.

Detailed description

The study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel, for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy. The aim of this study is to assess whether the daily consumption of AB-DENTALAC gum allows the colonization of strains L.plantarum KABP051 (CECT7481) and L.brevis KABP052 (CECT7480) in the oral microbiota, and to confirm the absence of side effects, with the following setup: 1. Number of patients to be randomized:40 2. Number of visits per patient: 2 The study will determine the index of plaque and gingival index as a measure of oral health. The presence of Lactobacillus in the samples collected by qPCR will also be quantified. The patient will benefit from a buccal revision and control by a periodontist for 6 weeks. It will also help subsequent patients to obtain a better treatment (if the results are significant). No harm is expected to participate, it is a minimal risk study, with non-invasive exploratory tests and a product suitable for human consumption and marketed in Europe since 2012. The potential patients to participate in the study will be healthy patients, so if they do not wish to participate they will not need alternative treatment. The objective of the study is to see if the probiotic is able to colonize the mouth in healthy patients, it is not a study to demonstrate the effectiveness of the product. If there is any serious adverse effect (something totally unexpected being a product with probiotic strains QPS), the patient will be advised to stop taking the product immediately. It is not anticipated that the use of any additional treatment is necessary. The promoter will provide all the necessary material for the study: 60 cases of placebo chewing gum, 60 cases of probiotic chewing gum, and cleaning material (toothbrush and fluoridated toothpaste) for all patients. Statistical analysis of bacterial colonization will be performed using Student's T with logarithmic transformation of data if required, considering a two-tailed P \<0.05 as significance cut-off.

Conditions

• Periodontal Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AB-DENTALAC [Probiotics (study)]	Treatment for 6 weeks, which will consist of the consumption of a chewing gum AB-DENTALAC with 100mg L.plantarum + L.brevis Probiotics blend (5E+8 CFU each at the end of shelf life), b.i.d (morning and evening).
DIETARY_SUPPLEMENT	Placebo (control)	Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening).

Timeline

• Start date: 2016-10-13
• Primary completion: 2016-11-24
• Completion: 2017-02-27
• First posted: 2018-05-30
• Last updated: 2019-12-18