EP2379091A2 - Zusammensetzungen und verfahren für die verbesserte mundgesundheit - Google Patents

Zusammensetzungen und verfahren für die verbesserte mundgesundheit

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Publication number
EP2379091A2
EP2379091A2 EP09793395A EP09793395A EP2379091A2 EP 2379091 A2 EP2379091 A2 EP 2379091A2 EP 09793395 A EP09793395 A EP 09793395A EP 09793395 A EP09793395 A EP 09793395A EP 2379091 A2 EP2379091 A2 EP 2379091A2
Authority
EP
European Patent Office
Prior art keywords
composition
bacteria
lactobacillus
health
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09793395A
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English (en)
French (fr)
Inventor
Zamzam Kabiry Roughead
Kala Marie Kaspar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nestec SA
Original Assignee
Nestec SA
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Filing date
Publication date
Application filed by Nestec SA filed Critical Nestec SA
Publication of EP2379091A2 publication Critical patent/EP2379091A2/de
Withdrawn legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A23G3/366—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing microorganisms, enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present disclosure is direct to medical treatments. More specifically, the present disclosure is directed to compositions and methods for improving the oral health of an individual.
  • dysphagia a prevalence rate for dysphagia among those over the age of 5 years to be 16% to 22% among individuals.
  • dysphagia There are 2 broad categories of dysphagia: (i) esophageal dysphagia, and (ii) oral pharyngeal dysphagia.
  • Esophageal dysphagia affects a large number of individuals of all ages, but is generally treatable with medications and is considered a less serious form of dysphagia. Esophageal dysphagia is often a consequence of mucosal, mediastinal, or neuromuscular diseases.
  • Mucosal (intrinsic) diseases narrow the lumen through inflammation, fibrosis, or neoplasia associated with various conditions (peptic stricture secondary to gastroesophageal reflux disease, esophageal rings and webs [sideropenic dysphagia or Plummer- Vinson syndrome], esophageal tumors, chemical injury [e.g., caustic ingestion, pill esophagitis, sclerotherapy for varices], radiation injury, infectious esophagitis, and eosinophilic esophagitis).
  • various conditions preptic stricture secondary to gastroesophageal reflux disease, esophageal rings and webs [sideropenic dysphagia or Plummer- Vinson syndrome], esophageal tumors, chemical injury [e.g., caustic ingestion, pill esophagitis, sclerotherapy for varices], radiation injury, infectious esophagitis, and eosinophilic es
  • Mediastinal (extrinsic) diseases obstruct the esophagus by direct invasion or through lymph node enlargement associated with various conditions (tumors [e.g., lung cancer, lymphoma], infections [e.g., tuberculosis, histoplasmosis], and cardiovascular [dilated auricula and vascular compression]).
  • tumors e.g., lung cancer, lymphoma
  • infections e.g., tuberculosis, histoplasmosis
  • cardiovascular diilated auricula and vascular compression
  • Neuromuscular diseases may affect the esophageal smooth muscle and its innervation, disrupting peristalsis or lower esophageal sphincter relaxation, or both, commonly associated with various conditions (achalasia [both idiopathic and associated with Chagas disease], scleroderma, other motility disorders, and a consequence of surgery [i.e., after fundoplication and antireflux interventions]). It is also common for individuals with intraluminal foreign bodies to experience acute esophageal dysphagia. [0004] Oral pharyngeal dysphagia, on the other hand, is a very serious condition and is generally not treatable with medication.
  • Oral pharyngeal dysphagia also affects individuals of all ages, but is more prevalent in older individuals. Worldwide, oral pharyngeal dysphagia affects approximately 22 million people over the age of 50. Oral pharyngeal dysphagia is often a consequence of an acute event, such as a stroke, brain injury, or surgery for oral or throat cancer. In addition, radiotherapy and chemotherapy may weaken the muscles and degrade the nerves associated with the physiology and nervous innervation of the swallow reflex.
  • oropharyngeal dysphagia include those associated neurological illnesses (brainstem tumors, head trauma, stroke, cerebral palsy, Guillain-Barre syndrome, Huntington's disease, multiple sclerosis, polio, post-polio syndrome, Tardive dyskinesia, metabolic encephalopathies, amyotrophic lateral sclerosis, Parkinson's disease, dementia), infectious illnesses (diphtheria, botulism, Lyme disease, syphilis, mucositis [herpetic, cytomegalovirus, Candida, etc.], autoimmune illnesses (lupus, scleroderma, Sjogren's syndrome), metabolic illnesses (amyloidosis, cushing's syndrome, thyrotoxicosis, Wilson's disease), myopathic illnesses (connective tissue disease, dermatomyositis, myasthenia grav
  • Aspiration pneumonia is a common clinical consequence of dysphagia. The condition often requires acute hospitalization and emergency room visits. Among those that develop pneumonia due to aspiration, the differential diagnosis of "aspiration pneumonia" is not necessarily indicated as a result of current care practices. [0007] Based on US healthcare utilization surveys from recent years, pneumonia accounted for over 1,000,000 hospital discharges and an additional 392,000 were attributable to aspiration pneumonia. Individuals who have general pneumonia as the principal diagnosis have a mean 6 day hospital length of stay and incur over $18,000 in costs for hospital care. It is expected that aspiration pneumonia would carry higher costs for hospital care based on a mean 8 day length of hospital stay.
  • Pneumonia is life threatening among persons with dysphagia, and the odds of death within 3 months is -50%.
  • an acute insult such as pneumonia often initiates the downward spiral in health among elderly.
  • An insult is associated with poor intakes and inactivity, resulting in malnutrition, functional decline, and frailty. For example, elderly commonly aspirate oropharyngeal contents during sleep.
  • Aspiration pneumonia is thought to be caused by the aspiration of colonized nasopharynx or oropharynx material secondary to dysphagia. Forceful coughing, active ciliary transport and normal immune response are presumed to be protective but are inadequate. Microflora present in the oral cavity because of poor oral hygiene have been associated with aspiration pneumonia.
  • the current standard of care for reducing incidence of aspiration pneumonia in patients with clinically-diagnosed swallowing disorders is chemical disinfection and use of antimicrobial agents to improve oral health. Additionally, another method called selective decontamination is used. This method is a prophylactic technique in which antimicrobials eradicate aerobic gram negative bacteria from the oropharynx while preserving the normal oral microbial flora.
  • the agents include oral antimicrobial gels with antibiotics, liquid suspensions with same administered through a nasogastric (“NG”) tube, intravenous (“IV”) antibiotics and stringent infection control.
  • compositions and methods for preventing and treating illnesses associated with oral health can provide: (i) a reduction in the incidence of aspiration pneumonia, (ii) less gingivitis and plaque, and (iii) improved tongue flora.
  • the source of chronic microbial challenge to the host can be targeted, which can reduce chronic inflammation on the host, help to restore an adequate immune response to physiological challenges and reduce an individual's risk of infections.
  • the present disclosure provides a nutritional composition for improving oral health.
  • the composition includes a therapeutically effective amount of a beneficial bacteria such as Lactobacillus reuteri, Lactobacillus plantarum, streptococcus Salivarius, Streptococcus salivarius K12, Lactobacillus reuteri ATCC55730, Lactobacillus johnsonii LaI, Lactobacillus plantarum 299v, Lactobacillus rhamnosus GG Streptococcus thermophilus NCC 1561, Lactococcus lactis NCC2211 (Pelargon strain), and Lacteol, and Other Ingredients with desired properties in accordance with the present invention include: CGMP which has been shown in testing to prevent binding of pathogens or a combination thereof.
  • the beneficial bacteria can include one or more bacteria normally indigenous to the oral cavity.
  • the beneficial bacteria can include one or more strains normally indigenous to the oral cavity such as streptococcus Salivarius K12, Lactobacillus platarum 299, Lactobacillus platarum 299v or a combination thereof.
  • the beneficial bacteria can be living or inactivated.
  • the composition is in a form such as liquids, solids, semisolids or a combination thereof.
  • the composition can be a complete oral nutritional supplement.
  • the composition can also be in a form such as lozenges, lollipops, sachets, dissolvable films or a combination thereof.
  • the composition is in a form such as a food, a beverage and combinations thereof.
  • the composition can include an ingredient such as a thickener.
  • the composition is a topical compound that can be applied to the surface of the oral cavity.
  • the present disclosure provides a method of reducing the incidence of aspiration pneumonia.
  • the method comprises administering to a patient at risk of or having aspiration pneumonia a therapeutically effective amount of a composition comprising a beneficial bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus plantarum, streptococcus Salivarius, Streptococcus salivarius Kl 2, Lactobacillus reuteri ATCC55730, Lactobacillus johnsonii LaI, Lactobacillus plantarum 299v, Lactobacillus rhamnosus GG Streptococcus thermophilus NCC 1561, Lactococcus lactis NCC2211 (Pelargon strain), and Lacteol, and Other Ingredients with desired properties in accordance with the present invention include: CGMP which has been shown in testing to prevent binding of pathogens and combinations thereof.
  • the present disclosure provides a method of improving oral health.
  • the method comprises administering to a patient at risk of or having oral health problems a composition comprising a therapeutically effective amount of a beneficial bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus plantarum, streptococcus Salivarius, Streptococcus salivarius K12, Lactobacillus reuteri ATCC55730, Lactobacillus johnsonii LaI, Lactobacillus plantarum 299v, Lactobacillus rhamnosus GG Streptococcus thermophilus NCC 1561, Lactococcus lactis NCC2211 (Pelargon strain), and Lacteol, and Other Ingredients with desired properties in accordance with the present invention include: CGMP which has been shown in testing to prevent binding of pathogens and combinations thereof.
  • the present disclosure provides a method of reducing healthcare costs.
  • the method comprises administering to a patient at risk of or having oral health problems a composition comprising a therapeutically effective amount of a beneficial bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus plantarum, streptococcus Salivarius, Streptococcus salivarius K12, Lactobacillus reuteri ATCC55730, Lactobacillus johnsonii LaI, Lactobacillus plantarum 299v, Lactobacillus rhamnosus GG Streptococcus thermophilus NCC 1561, Lactococcus lactis NCC2211 (Pelargon strain), and Lacteol, and Other Ingredients with desired properties in accordance with the present invention include: CGMP which has been shown in testing to prevent binding of pathogens, and combinations thereof.
  • the reduction in healthcare costs can be due to decreased incidences of aspiration pneumonia or general pneumonia that may not be differentially diagnosed.
  • the reduction in healthcare costs can be due to a reduced treatment of secondary infections and/or prevention of a downward spiral in health. This can include, for example, loss of functionality, frailty, disability and death.
  • the reduction in healthcare costs be due to improved overall health of the patient or due to decreased dental costs.
  • the reduction in healthcare costs can be due to decreased utilization of hospitals and skilled nursing facilities. Decreased utilization can be fewer days, fewer number of admissions, fewer ER visits, decreased incidences of aspiration pneumonia.
  • the reduction in healthcare costs can also be due to decreased utilization of specialized care.
  • the reduction in healthcare costs can also be due to decreased utilization of antibiotics and/or artificial ventilation and/or pulmonary rehabilitation and/or physical therapy post- ventilation and/or intravenous fluids.
  • the decreased utilization can be due to a decreased need for prevention of aspiration pneumonia.
  • the decreased utilization can be due to treatment of sequellae from antibiotic use.
  • the sequellae can be fungal infections (thrush), or urinary tract infections ("UTIs"), or C difficile associated diarrhea or a combination thereof.
  • the sequellae can also be infections from antibiotic resistant bacteria, methicillin-resistant Staphylococcus aureus, or a combination thereof.
  • the decreased sequellae from antibiotic use can be due to decreased incidences of infections from antibiotic resistant bacteria.
  • An advantage of the present disclosure is to provide a composition for improving oral health.
  • Another advantage of the present disclosure is to provide a method for improving oral health.
  • Yet another advantage of the present disclosure is to provide a method for reducing the incidence of aspiration pneumonia.
  • Still another advantage of the present disclosure is to provide a method of reducing health care costs.
  • compositions and methods for preventing and treating illnesses associated with oral health can be used to reduce improve oral health such reducing the incidence of aspiration pneumonia.
  • the compositions and methods can also be used to reduce the healthcare costs associated with treating the effects of adverse oral health conditions.
  • compositions and methods in embodiments of the present disclosure are beneficial for individuals or patients with clinical (diagnosed), subclinical (undiagnosed), or at risk of disorders of swallowing.
  • Patients with swallowing difficulties such as those clinically diagnosed with dysphagia or those at risk of developing dysphagia can be malnourished or elderly and have Parkinson's, Alzheimer disease, dementia, head and neck cancer, stroke, Down's syndrome or conditions leading to protruded tongue.
  • compositions and methods can provide health benefits to patients at risk or having silent aspiration (e.g. aspirate during sleep or any other time such as while reclined) and those at risk of or who have had pneumonia (e.g. recurrent pneumonias, immune-compromised persons).
  • the compositions and methods can provide health benefits to those who are at risk of or have poor oral health (e.g. secondary to medication use, decreased saliva production, smoking/tobacco use, alcohol use, liver failure, infrequently practice oral hygiene methods, functionally-impaired who require assistance with oral care).
  • the term "patient” is preferably understood to include an animal, especially a mammal, and more especially a human that is receiving or intended to receive treatment, as it is herein defined.
  • mammal includes but is not limited to rodents, aquatic mammals, domestic animals such as dogs and cats, farm animals such as sheep, pigs, cows and horses, and humans. Wherein the term mammal is used, it is contemplated that it also applies to other non-mammal animals that are capable of the effect exhibited or intended to be exhibited by the mammal.
  • complete nutrition are preferably nutritional products that contain sufficient types and levels of macronutrients (protein, fats and carbohydrates) and micronutrients to be sufficient to be a sole source of nutrition for the animal to which it is being administered to.
  • macronutrients protein, fats and carbohydrates
  • micronutrients micronutrients
  • an effective amount is preferably an amount that prevents a deficiency, treats a disease or medical condition in an individual or, more generally, reduces symptoms, manages progression of the diseases or provides a nutritional, physiological, or medical benefit to the individual.
  • a treatment can be patient- or doctor- related.
  • the terms “individual” and “patient” are often used herein to refer to a human, the invention is not so limited. Accordingly, the terms “individual” and “patient” refer to any animal, mammal or human having or at risk for a medical condition that can benefit from the treatment.
  • infant nutrition are preferably nutritional products that do not contain sufficient levels of macronutrients (protein, fats and carbohydrates) or micronutrients to be sufficient to be a sole source of nutrition for the animal to which it is being administered to.
  • macronutrients protein, fats and carbohydrates
  • micronutrients to be sufficient to be a sole source of nutrition for the animal to which it is being administered to.
  • Long term administrations are preferably continuous administrations for more than 6 weeks.
  • microorganism is meant to include the bacterium, yeast and/or fungi, a cell growth medium with the microorganism or a cell growth medium in which microorganism was cultivated.
  • a "Prebiotic” is preferably a food substances that selectively promote the growth of beneficial bacteria or inhibit the growth of pathogenic bacteria in the intestines. They are not inactivated in the stomach and/or upper intestine or absorbed in the GI tract of the person ingesting them, but they are fermented by the gastrointestinal microflora and/or by probiotics. Prebiotics are for example defined by Glenn R. Gibson and Marcel B. Roberfroid, Dietary Modulation of the Human Colonic Microbiota: Introducing the Concept of Prebiotics, J. Nutr. 1995 125: 1401-1412.
  • Probiotics micro-organisms are preferably microorganisms (alive, including semi-viable or weakened, and/or non- replicating), metabolites, microbial cell preparations or components of microbial cells that could confer health benefits on the host when administered in adequate amounts, more specifically, that beneficially affect a host by improving its intestinal microbial balance, leading to effects on the health or well-being of the host.
  • probiotics are preferably microorganisms (alive, including semi-viable or weakened, and/or non- replicating), metabolites, microbial cell preparations or components of microbial cells that could confer health benefits on the host when administered in adequate amounts, more specifically, that beneficially affect a host by improving its intestinal microbial balance, leading to effects on the health or well-being of the host.
  • micro-organisms inhibit or influence the growth and/or metabolism of pathogenic bacteria in the intestinal tract.
  • the probiotics may also activate the immune function of the host. For this reason, there have been many different approaches to include probiotics into food products.
  • Short term administrations are preferably continuous administrations for less than 6 weeks.
  • the terms "Tolerable Upper Limit and Upper Limit (UL)” are preferably meant to include the maximum nutrient level that will likely pose no risk of adverse events.
  • treatment is preferably to both prophylactic or preventive treatment (that prevent and/or slow the development of a targeted pathologic condition or disorder) and curative, therapeutic or disease-modifying treatment, including therapeutic measures that cure, slow down, lessen symptoms of, and/or halt progression of a diagnosed pathologic condition or disorder; and treatment of patients at risk of contracting a disease or suspected to have contracted a disease, as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition.
  • prophylactic or preventive treatment that prevent and/or slow the development of a targeted pathologic condition or disorder
  • curative, therapeutic or disease-modifying treatment including therapeutic measures that cure, slow down, lessen symptoms of, and/or halt progression of a diagnosed pathologic condition or disorder
  • treatment of patients at risk of contracting a disease or suspected to have contracted a disease as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition.
  • the term does not necessarily imply that a subject is treated until total recovery.
  • treatment also refer to the maintenance and/or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition, such as nitrogen imbalance or muscle loss.
  • treatment also intended to include the potentiation or otherwise enhancement of one or more primary prophylactic or therapeutic measure.
  • treatment is further intended to include the dietary management of a disease or condition or the dietary management for prophylaxis or prevention a disease or condition
  • “Comensal bacteria” are those microorganisms that help the digestion of food and acquiring of nutrients such as vitamins B and K, and assisting the immune system in preventing the colonization of pathogens that cause disease by competing with them.
  • a “Comensal Effect” is when a microorganism, by itself, or aids another organism in helping the digestion of food and acquiring of nutrients such as vitamins B and K, and assisting the immune system in preventing the colonization of pathogens that cause disease by competing with them.
  • compositions and methods in embodiments of the present disclosure provide superior alternatives to current standards of care for improving oral health.
  • the compositions and methods can be used to supplement beneficial bacteria in the oropharynx of the patient.
  • the compositions and methods can provide competitive inhibition through displacing pathogenic bacteria by competing for adhesion sites and nutrients.
  • the compositions and methods can restore micro floral balance in the patient's oropharynx, esophagus, and the rest of the gastrointestinal (“GI”) tract.
  • GI gastrointestinal
  • compositions and methods do not need to be used in conjunction with ventilators that can collect pathogens (e.g., reservoir) and provide a place to attack them wherein. Under normal circumstances, there is no place for the bacteria to be static/colonize, etc.
  • pathogens e.g., reservoir
  • compositions and methods can utilize natural, indigenous probiotics that reduce salivary pathogenic bacterial load in the oropharynx and nasopharynx.
  • natural, indigenous probiotics can offer oral health without killing the other bacteria or inducing antibiotic-resistance.
  • certain probiotics can kill pathogenic bacteria and inhibit their reproduction (e.g. /. reuteri produce natural antiobiotics that kill pathogens).
  • the probiotics can compete with receptor signaling sites that mediate systemic inflammation. As a result, the ingested probiotics can then confer immune and gut health benefits.
  • An advantage of this ingestion can be multifold as it addresses the immune response of the patient from the oral cavity to systemic immune response.
  • compositions and methods in alternative embodiments of the present disclosure can reduce the use of antibiotics in a dysphagia patient, reduce pathogenic bacterial load in a dysphagia patient, reduce pathogenic bacterial load in the oropharynx of a dysphagia patient, reduce pathogenic bacterial load in the nasopharynx of a dysphagia patient, reduce pathogenic bacterial load in the oropharynx and nasopharynx of a dysphagia patient, reduce pathogenic bacterial load in dysphagia patients (e.g. wherein the pathogenic bacterial is AGNB), and improve the overall health and cardiovascular of the patient.
  • the pathogenic bacterial is AGNB
  • compositions and methods in embodiments of the present disclosure can utilize a therapeutically effective amount of live or inactivated beneficial bacteria (e.g. probiotics) as follows: a. Delivered orally i) Alone
  • CGMP which has been shown in testing to prevent binding of pathogens and is known to be effective against Streptococcus mutans and Streptococcus sobrinus.
  • compositions in embodiments of the present disclosure as part of daily life can improve oral health by replacing the pathogenic bacteria with beneficial, non-pathogenic bacteria.
  • Oral health can also be improved as a result of the releasing of beneficial chemicals by the bacteria (e.g. anti-microbials).
  • beneficial chemicals e.g. anti-microbials.
  • the pathogenic bacterial load will be low and the likelihood of onset of aspiration pneumonia can be reduced.
  • Non- limiting examples of bacteria to be used in accordance with this invention include one or more of: Streptococcus salivarius Kl 2, Lactobacillus reuteri ATCC55730, Lactobacillus johnsonii LaI, Lactobacillus plantarum 299v, Lactobacillus rhamnosus GG Streptococcus thermophilus NCC 1561, Lactococcus lactis NCC2211 (Pelargon strain), and Lacteol.
  • Streptococcus salivarius Kl 2 which produces produce salivaricin A and B, in testing has been shown to be effective against Streptococus pyogenes, Micrococcus luteus, Streptococcus anginosis, Eubacterium saburreum, Micromonas micros, Moraxella, Prevotella intermedia, and Porphyomonas gingivalis,
  • Lactobacillus reuteri ATCC55730 which produces reuterin, in testing has been shown to be effective against: Streptococcus mutans, EHEC Escherichia coli, ETEC Escherichia coli, Salmonella enterica, Shigella sonnei, Vibrio cholerae. Additionally, Lactobacillus reuteri ATCC55730 has a commensal effect on L. casei ATCC 334, L. johnson ⁇ ATCC33200, L. acidophilus ATCC 4356, L.
  • gasseri ATCC 33323 Clostridium difficile, Eubacterium eligens, Bifidobacterium longum var infantis, Eubacterium biforme, Bifidobacterium longum, Bifidobacterium catenulatum, Bacteroides vulgatus, and Bacteroides thetaiotaomicron.
  • Lactobacillus johnsonii LaI which produces H2O2, in testing has been shown to be effective against: Escherichia coli (ETEC, EPEC), Salmonella typhimurium, Yersinia pseudotuberculosis, Helocobacter pylori, Toxin A from Clostridium difficile, Shigella flexneri, Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Staphylococcus aureus, and Listeria monocytogenes.
  • ETEC Escherichia coli
  • Salmonella typhimurium typhimurium
  • Yersinia pseudotuberculosis Helocobacter pylori
  • Toxin A from Clostridium difficile Shigella flexneri
  • Klebsiella pneumoniae Pseudomonas aeruginosa
  • Enterobacter cloacae Staphylococcus aureus
  • Lactobacillus plantarum 299v has been shown to help prevent colonisation of pathogens, and aids in preventing ventilation associated pneumoniae (VAP). Testing has shown that LP299v is effective against: Streptococcus mutans, Streptococcus sobrinus, and Escherichia coli.
  • Lactobacillus rhamnosus GG has also been shown to help prevent colonisation of pathogens, and aids in preventing ventilation associated pneumoniae (VAP). Testing has shown that Lactobacillus rhamnosus GG is effective against Streptococcus mutans, Streptococcus sobrinus, and Escherichia coli.
  • Streptococcus thermophilus NCC 1561 in testing has been shown to be effective against Actinomyces viscosus, and Strepotcoccus sobrinus.
  • Lactococcus lactis NCC2211 (Pelargon strain), in testing has been shown to be effective against Actinomyces viscosus and Strepotcoccus sobrinus. Examples of Non-Replicating Micro-organisms include
  • Lacteol which acts by a mechanismof inhibition of adhesion of pathogens (adheres to Caco 2 and HT29-MRX cells) and has been shown in testing to prevent adhering of Lysteria monocytogenes, ETEC Escherichia coli, EPEC Escherichia coli, Yersinia pseudotuberculosis, and Salmonella typhimurium.
  • Lacteol has been shown to have antimicrobial activity against: Staphylococcus aureus, Listeria monocytogenes, Bacillus cereus, Salmonella typhimurium, Shigella flexneri, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterobacter spp.
  • the present disclosure provides a method of reducing healthcare costs.
  • the method comprises administering to a patient at risk of or having oral health problems a composition comprising a therapeutically effective amount of a beneficial bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus plantarum, streptococcus Salivarius, Streptococcus salivarius K12, Lactobacillus reuteri ATCC55730, Lactobacillus johnsonii LaI, Lactobacillus plantarum 299v, Lactobacillus rhamnosus GG Streptococcus thermophilus NCC 1561, Lactococcus lactis NCC2211 (Pelargon strain), and Lacteol and combinations thereof.
  • a beneficial bacteria selected from the group consisting of Lactobacillus reuteri, Lactobacillus plantarum, streptococcus Salivarius, Streptococcus salivarius K12, Lactobacillus reuteri AT
  • the reduction in healthcare costs can be due to decreased incidences of aspiration pneumonia or general pneumonia that may not be differentially diagnosed.
  • the reduction in healthcare costs can be due to a reduced treatment of secondary infections and/or prevention of a downward spiral in health. This can include, for example, loss of functionality, frailty, disability and death.
  • the health economic benefits can be as follows:
  • MRSA Methicillin-resistant Staphylococcus aureus
  • Table 1 lists components for a complete feeding product (powder or liquid) appropriate for nutritional supplementation of patients with or at risk of dysphagia, those at high risk of aspiration, at high risk of pneumonia, and at risk of poor oral health.
  • compositions having thickeners that are appropriate for nutritional supplementation of patients with or at risk of dysphagia, those at high risk of aspiration, at high risk of pneumonia, and at risk of poor oral health can include components of Table 2.
  • the thickeners can be starches, gums or other plant or animal based thickeners.
  • Modular powders or liquid supplements appropriate for nutritional supplementation of patients with or at risk of dysphagia, those at high risk of aspiration, at high risk of pneumonia, and at risk of poor oral health can include components of Table 3.

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