Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate the Clinical Efficacy of Streptococcus Dentisani CECT 7746 in Caries Risk Reduction

Exploratory, phase I study to evaluate the clinical efficacy of Streptococcus dentisani CECT 7746 in the risk reduction of caries. Patients who meet the inclusion and exclusion criteria will be randomized and receive the corresponding treatment. The study will follow a randomized design, with two groups in parallel (placebo group and probiotic group) of prospective, double-blind follow-up, for a period of 45 days. The present study will be conducted in a single center and will include a total of 70 patients. The present study has a double main objective:
Evaluate whether the administration of the probiotic S. dentisani CECT 7746 alkalizes the basal pH of saliva.
Test the safety and tolerability of the probiotic
Secondary
Evaluate other microbiological parameters associated with caries risk such as the presence of microorganisms such as S. mutans.
Evaluate the presence in the mouth and colonization capacity of S. dentisani.
Evaluate the lactic acid and the pH of the ex vivo plate before and after the administration of a sugar solution
Evaluate the salivary pH before and after the administration of a sugar solution
Evaluate the salivary pH before brushing with water.
Evaluate the buffer capacity of saliva

Start Date13 May 2016

Sponsor / Collaborator

AB-Biotics SA

100 Clinical Results associated with Probiotic CECT 7746(AB Biotics)

100 Translational Medicine associated with Probiotic CECT 7746(AB Biotics)

100 Patents (Medical) associated with Probiotic CECT 7746(AB Biotics)

Literatures (Medical) associated with Probiotic CECT 7746(AB Biotics)

Frontiers in Cellular and Infection MicrobiologyQ2 · MEDICINE

Isolation and Bacteriocin-Related Typing of Streptococcus dentisani

Q2 · MEDICINE

ArticleOA

Author: Westenberger, Jacqueline ; Conrads, Georg ; Abdelbary, Mohamed M H ; Lürkens, Martha

Streptococcus oralis subspecies dentisani is explored as an anti-cariogenic probiotic. Here, subjecting freshly stimulated saliva samples of 35 healthy volunteers, six epidemiologically unrelated and two related strains were isolated (prevalence around 20%) applying a newly developed three-step procedure. Furthermore, the probiotic strain S. dentisani 7746 (AB-Dentisanium®) was tested under a variety of environmental conditions for its inhibitory effect on six S. mutans, two S. sobrinus, 15 other oral or intestinal streptococci, 15 S. dentisani strains, and six representatives of other species including periodontopathogens. All except one of the S. mutans strains were inhibited by 7746 colonies or culture supernatant concentrate but only if either the test cell number was low or the producer or its bacteriocin concentration, respectively, was high. S. sanguinis OMI 332, S. salivarius OMI 315, S. parasanguinis OMI 335, S. vestibularis OMI 238, and the intestinal S. dysgalactiae OMI 339 were not inhibited, while the other 10 streptococcal strains (especially S. oralis OMI 334 and intestinal S. gallolyticus OMI 326) showed a certain degree of inhibition. From the panel of other bacterial species only Aggregatibacter actinomycetemcomitans was slightly inhibited. With the exception of OMI 285 and OMI 291 that possessed a 7746 bacteriocin-like gene cluster, all S. dentisani strains and especially type strain 7747^T were strongly inhibited by 7746. In conclusion, probiotic strain 7746 might antagonize the initiation and progression of dental caries by reducing S. mutans if not too abundant. S. dentisani strains inhibit each other, but strains with similar bacteriocin-related gene clusters, including immunity genes, are able to co-exist due to cross-resistance. In addition, development of resistance and adaptation to 7746-bacteriocins was observed during our study and needs attention. Hence, mechanisms underlying such processes need to be further investigated using omics-approaches. On the manufacturing level, probiotic strains should be continuously tested for function. Further clinical studies investigating inhibition of S. mutans by AB-Dentisanium® are required that should also monitor the impact on the oral microbiome composition including resident S. dentisani strains.

100 Deals associated with Probiotic CECT 7746(AB Biotics)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Dental Caries	Phase 1	ES	AB-Biotics SA	13 May 2016
Gingivitis	Phase 1	ES	AB-Biotics SA	13 May 2016
Periodontitis	Phase 1	ES	AB-Biotics SA	13 May 2016
Stomatodysodia	Phase 1	ES	AB-Biotics SA	13 May 2016

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