Use Of Blis K12 Throat Guard For Chronic BadBreath

BLIS Technologies today announced the results of its recently completed clinical trials carried out using BLIS K12 Throat Guard on sufferers of chronic bad breath.

“These trials have shown that for the majority of sufferers of chronic bad breath tested, use of BLIS K12 Throat Guard resulted in a significant improvement in breath scores,” Dr Chris Chilcott, BLIS Technologies head of research said.

“The 13 subjects in the trial averaged pre-treatment breath readings which placed many of them in the range of bad breath odour being discernable several feet away. Following use of BLIS K12 Throat Guard, a week later 11 of the 13 recorded breath readings below the range associated with bad breath even when tested first thing in the morning before any oral care. Eight of these 11 maintained good breath levels when tested first thing in the morning a further week later.’

Mr. Kelvin Moffatt, BLIS Technologies chief executive, said that the results of this trial would be presented at the International Conference for Breath Odour in London on April 22, and the company would be seeking publication of the full results of the trial in a peer reviewed scientific journal.

“Bad breath is a larger problem than often realised with studies showing 6-23% of the population suffer oral malodour with it being more prevalent with age.” (1)

“We believe that this treatment represents a breakthrough for those people who are currently forced to live with the social stigma of severe bad breath and its associated impact on their daily lives. While there are a number of possible causes of bad breath, around 80 to 90% of cases are due to undesirable bacteria that live on the back of the tongue. These people suffer from a basic imbalance in their oral microflora that normal oral hygiene practices often have little impact on. The use of BLIS K12 Throat Guard, which contains the beneficial oral bacterium Streptococcus salivarius K12, aims to treat the root cause of their bad breath by restoring a bacterial balance associated with healthy breath.

Dr. Jeremy Burton head of clinical trials for BLIS Technologies said that while there were only 13 subjects in the trial, this data would be well received internationally because investigators in this area understood the difficulty in recruiting high numbers of subjects with severe bad breath in this sensitive area.

Further double blind, placebo controlled studies were planned in conjunction with the University of Otago Dental School to build on this initial data.

These trials took place as a result of a US based research group finding that: People with healthy breath typically have high levels of the beneficial oral bacterium Streptococcus salivarius living on their tongues. People who suffer from chronic bad breath either lack, or have very low levels, of the normally predominant Streptococcus salivarius, and their tongues are inhabited by undesirable bacteria often responsible for bad breath. (2)

BLIS K12 THROAT GUARD aimed firstly to reduce the number of undesirable bacteria that live in the mouth of subjects that suffered chronic bad breath, and then re-colonise with Streptococcus salivarius K12 to help prevent re-growth of the malodour bacteria. Streptococcus salivarius K12 is a naturally occurring strain of bacteria that produces BLIS (Bacteriocin-Like Inhibitory Substances) compounds that inhibit the growth of other undesirable strains of bacteria.

“We anticipate that an initial promotional campaign for the use of BLIS K12 Throat Guard for bad breath prevention would begin in the next few months, and an announcement on the appointment of partners in key international markets is also expected in the near future,” Mr Moffatt said.

BLIS K 12 is a Dietary Supplement. Use as directed. If symptoms persist then medical advice should be sought. BLIS K12 will help assist the throat’s natural defences during bacterial but not viral infections. People suffering from immune compromised conditions should seek the advice of their doctor before taking the product. Each lozenge contains one hundred million viable cells of Streptococcus salivarius K12. BLIS Technologies Limited, Wellington.

TAPS approval NA 8838

Issued on behalf of BLIS Technologies by Sorensen Group, 04 472 4190.

FACT SHEET

About BLIS Technologies BLIS Technologies was formed in June 2000 to pursue the commercialisation of BLIS (bacteriocin-like inhibitory substances). In an unusual move for a new company, BLIS Technologies was listed on the New Zealand Stock Exchange less than a year after it was set up. The company has its own research laboratory based at Otago University’s Centre for Innovation. The research team comprises among others: the University of Otago Professor of Microbiology, Professor John Tagg; BLIS Technologies’ Director of Science, Dr Chris Chilcott; and Dr Jeremy Burton, Clinical Trials Manager.

Trials Methodology Thirteen subjects with volatile sulphur compound (VSC) breath readings of greater 200 parts per billion on two separate visits were recruited for the study. (3)

The subjects undertook a three-day regimen of tongue cleaning and chlorhexidine use followed by the sucking of four BLIS K12 lozenges each day. The subjects then ceased using the chlorhexidine and took just two BLIS K12 lozenges per day for a total of two weeks. At each pre-treatment visit and at one and two weeks after treatment the subjects were tested for breath VSC levels; saliva samples and tongue swabs were also taken for analysis. All measurements were taken in the morning prior to the subjects eating, drinking or using any oral care.

VSC readings in persons with normal breath are typically in the range of 80-150 ppb.

At levels of 200-300 ppb, oral malodour is noticeable by an observer standing close to the patient. At 350-400 ppb, the odour is noticeable by an observer standing several feet away from the patient.

Trial outcome i) The VSC levels of eight subjects were significantly lower when tested at one and two weeks after commencing treatment. Average results are presented in the following table.
Average VSC’s Pre-treatment Visit one Average VSC’s Pre-treatment Visit two Average VSC’s Post treatment Seven days Average VSC’s Post treatment Fourteen days
365 371 159 151

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ii) The VSC levels of three subjects were significantly lower when tested at one week after commencing treatment, but had returned to pre-treatment levels at day fourteen. It may be that these subjects may require more regular use of a high dose regime to maintain high levels of S. salivarius colonisation.
Average VSC’s Pre-treatment Visit one Average VSC’s Pre-treatment Visit two Average VSC’s Post treatment Seven days Average VSC’s Post treatment Fourteen days
332 350 110 296
iii) Two subjects showed no improvement with the treatment and it may be that the cause of bad breath in these subjects was due to other causes than an imbalance of oral micro flora or alternatively that a more potent antimicrobial pre-treatment such as use of antibiotics may be required.

A control group of three subjects were also monitored using tongue cleaning and chlorhexidine use only, and showed no improvement in VSC levels at the seven-day point versus pre-treatment VSC levels.

Other adjunctive outcome measures in the trial such as organoleptic scoring of incubated saliva, reduction of BANA activity and changes in the PCR-DGGE profiles and cultural analysis of the oral microflora also generally correlated with the observed reduction in VSC levels.

Miyazaki H, Sakao S, Katoh Y, et al. Correlation between volatile sulphur compounds and certain oral health measurements in the general population. J Periodontol. 1995 Aug; 66(8): 679-84. Kazor CE, Mitchell PM, Lee AM, Stokes LN, Loesche WJ, Dewhirst FE, Paster BJ. Diversity of Bacterial Populations of the Tongue Dorsa of Patients with Halitosis and Healthy Patients. Journal of Clinical Microbiology 2003, 41; 2:(558-563). Burton JP(1), Chilcott CN(1), Moore CJ(1), Tagg JR(2). Effect of Probiotic Streptococcus salivarius K12 on Oral Malodour Parameters. International Conference for Breath Door, London, April 2004. 1BLIS Technologies and 2Department of Microbiology and Immunology, University of Otago, Dunedin, New Zealand.

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