Colonisation Efficacy of a Probiotic Chewing Gum.

NCT05624177 | Unknown

• 1 other identifier: BLTCT2022/7
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the colonization efficacy (the ability of a probiotic bacteria to remain in the mouth) delivered in a chewing gum format. The chewing gum contains Streptococcus salivarius probiotic and the study is to be done in health adults.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (4)

• Change in Microbial colonization from baseline (Day 0) to 1 hour.

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 1 hour across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

  1 hour post intervention.

• Change in Microbial colonization from baseline (Day 0) to 8 hours.

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

  8 hours post intervention.

• Change in Microbial colonization from baseline (Day 0) to 8 hours post last dose.

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 8 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

  8 hours past last dose following 7 days of twice daily administration of probiotic.

• Change in Microbial colonization from baseline (Day 0) to 48 hours post last dose.

  Study will determine the change in microbial colonization efficacy of Streptococcus salivarius M18 chewing gum after two different times of chewing (5 vs 10 minutes). The statistical analysis will be carried out to compare the participants saliva data from baseline to post 48 hours following twice daily administration of probiotic, across two different times of chewing exposure with a level of significance of p\<0.05. Overall colonization based on percentage of population colonized for different interventions will also be analyzed using appropriate statistical analysis software.

  48 hours past last dose following 7 days of twice daily administration of probiotic.

Study Arms (2)

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes

ACTIVE COMPARATOR

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 5 minutes duration.

Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes)

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes

ACTIVE COMPARATOR

Streptococcus salivarius M18 chewing gum 1 billion cfu chewing the gum for 10 minutes duration.

Dietary Supplement: Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes)

Interventions

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 5 minutes) DIETARY_SUPPLEMENT

Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 5 minutes

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum (chew 10 minutes) DIETARY_SUPPLEMENT

Probiotic Streptococcus salivarius M18 products are commercially available in traditional formats such as a chewable tablet (lozenge) for local delivery to the oral cavity to provide health benefits. In this study, a chewing gum formulation will be evaluated for its potential of delivering probiotic Streptococcus salivarius M18 to the oral cavity.

Streptococcus salivarius M18 probiotic 1 billion colony forming units chewing gum: Chew 10 minutes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In general, good health
• Practice good oral hygiene

You may not qualify if:

• Have a history of autoimmune disease or are immune compromised.
• Are on concurrent antibiotic therapy, or regular antibiotic use within last one week
• People with allergies or sensitivities to dairy.

Sponsors & Collaborators

• BLIS Technologies Limited: lead

Study Sites (1)

Blis Technologies Ltd

Dunedin, Otago, 9012, New Zealand

RECRUITING

Related Publications (9)

• Hyink O, Wescombe PA, Upton M, Ragland N, Burton JP, Tagg JR. Salivaricin A2 and the novel lantibiotic salivaricin B are encoded at adjacent loci on a 190-kilobase transmissible megaplasmid in the oral probiotic strain Streptococcus salivarius K12. Appl Environ Microbiol. 2007 Feb;73(4):1107-13. doi: 10.1128/AEM.02265-06. Epub 2006 Dec 28.

  PMID: 17194838 BACKGROUND

• Burton JP, Chilcott CN, Wescombe PA, Tagg JR. Extended Safety Data for the Oral Cavity Probiotic Streptococcus salivarius K12. Probiotics Antimicrob Proteins. 2010 Oct;2(3):135-44. doi: 10.1007/s12602-010-9045-4.

  PMID: 26781236 BACKGROUND

• Bardellini E, Amadori F, Gobbi E, Ferri A, Conti G, Majorana A. Does Streptococcus Salivarius Strain M18 Assumption Make Black Stains Disappear in Children? Oral Health Prev Dent. 2020 Apr 3;18(2):161-164. doi: 10.3290/j.ohpd.a43359.

  PMID: 32099975 BACKGROUND

• Burton JP, Drummond BK, Chilcott CN, Tagg JR, Thomson WM, Hale JDF, Wescombe PA. Influence of the probiotic Streptococcus salivarius strain M18 on indices of dental health in children: a randomized double-blind, placebo-controlled trial. J Med Microbiol. 2013 Jun;62(Pt 6):875-884. doi: 10.1099/jmm.0.056663-0. Epub 2013 Feb 28.

  PMID: 23449874 BACKGROUND

• Gregori G, Righi O, Risso P, Boiardi G, Demuru G, Ferzetti A, Galli A, Ghisoni M, Lenzini S, Marenghi C, Mura C, Sacchetti R, Suzzani L. Reduction of group A beta-hemolytic streptococcus pharyngo-tonsillar infections associated with use of the oral probiotic Streptococcus salivarius K12: a retrospective observational study. Ther Clin Risk Manag. 2016 Jan 19;12:87-92. doi: 10.2147/TCRM.S96134. eCollection 2016.

  PMID: 26855579 BACKGROUND

• Di Pierro F, Adami T, Rapacioli G, Giardini N, Streitberger C. Clinical evaluation of the oral probiotic Streptococcus salivarius K12 in the prevention of recurrent pharyngitis and/or tonsillitis caused by Streptococcus pyogenes in adults. Expert Opin Biol Ther. 2013 Mar;13(3):339-43. doi: 10.1517/14712598.2013.758711. Epub 2013 Jan 4.

  PMID: 23286823 BACKGROUND

• Di Pierro F, Colombo M, Zanvit A, Rottoli AS. Positive clinical outcomes derived from using Streptococcus salivarius K12 to prevent streptococcal pharyngotonsillitis in children: a pilot investigation. Drug Healthc Patient Saf. 2016 Nov 21;8:77-81. doi: 10.2147/DHPS.S117214. eCollection 2016.

  PMID: 27920580 BACKGROUND

• Di Pierro F, Colombo M, Giuliani MG, Danza ML, Basile I, Bollani T, Conti AM, Zanvit A, Rottoli AS. Effect of administration of Streptococcus salivarius K12 on the occurrence of streptococcal pharyngo-tonsillitis, scarlet fever and acute otitis media in 3 years old children. Eur Rev Med Pharmacol Sci. 2016 Nov;20(21):4601-4606.

  PMID: 27874935 BACKGROUND

• Di Pierro F, Zanvit A, Nobili P, Risso P, Fornaini C. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study. Clin Cosmet Investig Dent. 2015 Oct 3;7:107-13. doi: 10.2147/CCIDE.S93066. eCollection 2015.

  PMID: 26491371 BACKGROUND

MeSH Terms

Conditions

Communicable Diseases

Interventions

Mastication

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

John D Hale, PhD

CONTACT

+64211735540; john.hale@blis.co.nz

Rohit Jain, PhD

CONTACT

+64211347338; rohit.jain@blis.co.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A Staff member, not part of the study group will be assigned to distribute blinded samples. The investigator will not be are of the dose groups.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two groups consuming chewing gum containing Streptococcus salivarius M18. Group A: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 5 minutes duration. Group B: Probiotic Streptococcus salivarius M18 chewing gum (dose: 1 billion colony forming units per gum tablet) and chew for 10-20 minutes

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: December 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)