Pharmaceutical compositions containing pediococcus and methods for reducing the symptoms of gastroenterological syndromes

Abstract

The invention provides a method and composition for ameliorating or reducing the symptoms, signs, and markers and for the treatment of irritable bowel syndrome, inflammatory bowel disease or gastritis in a mammal in need thereof, said method comprising administering effective amounts of a pharmaceutically acceptable composition containing at least one probiotic microorganism strain comprising Pediococcus for a time sufficient to ameliorate, reduce or treat at least one symptom, sign, or marker of irritable bowel syndrome, inflammatory bowel disease or gastritis.

1 - 24 . (canceled) 
     
     
         25 . A pharmaceutically acceptable composition comprising at least one probiotic microorganism strain comprising  Pediococcus  in an amount sufficient to ameliorate at least one symptom of irritable bowel syndrome, inflammatory bowel disease, or gastritis in a mammal in need thereof. 
     
     
         26 . The composition of  claim 25 , wherein the  Pediococcus  strain is selected from the group comprising  Pediococcus acidilactici, Pediococcus pentosaceus, Pediococcus damnosus, Pediococcus dextrinicus , and  Pediococcus parvulus  and mixtures thereof. 
     
     
         27 . The composition according to  claim 26 , wherein a dose or serving of the pharmaceutical agent comprises from about 1 million to about 150 billion Colony Forming Units (CFU) of the  Pediococcus.    
     
     
         28 . The composition according to  claim 26 , wherein a dose or serving comprises about 150 billion CFU of the  Pediococcus  per gram of pharmaceutically acceptable composition. 
     
     
         29 . The composition according to  claim 26 , wherein the composition further contains at least one of a second probiotic microbial organism, wherein said second probiotic microbial organism is selected from the group of: a bacterium, a fungus or mixtures thereof. 
     
     
         30 . The composition of  claim 29 , wherein said second probiotic microbial organism is selected from the group comprising  Lactobacillus, Bifidobacterium  or  Saccharomyces.    
     
     
         31 . The composition according to  claim 30 , wherein the second probiotic microbial organism is selected from the group consisting of:  Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus bulgaricus, Lactobacillus casei, Lactobacillus crispatus, Lactobacillus curvatus, Lactobacillus fermentum, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus johnsonii, Lactobacillus paracasei, Lactobacillus paraplantarum, Lactobacillus pentosus, Lactobacillus plantarum, Lactobacillus reuteri, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus sakei, Bifidobacterium adolescentis, Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium infantis, Saccharomygces boulardii , and  Saccharomyces cereviseae  and mixtures thereof. 
     
     
         32 . The composition according to  claim 29 , wherein said second probiotic microbial organism is selected from the group consisting of:  Lactococcus lactis, Leuconostoc lactis, Leuconostoc pseudomesenteroides, Leuconostoc mesenteroides, Streptococcus thermophilus, Bacillus subtilis, Bacillus coagulans, Bacillus licheniformis, Bacillus cereus, Enterococcus faecium, Escherichia coli  Nessle 1917,  Proprionibacterium acidipropionici, Proprionibacterium freudenreichii, Proprionibacterium jensenii , and  Proprionibacterium thoenii  and mixtures thereof. 
     
     
         33 . The composition according to  claim 32 , wherein none of the probiotic microorganisms in the composition have been propagated or grown in media containing casein. 
     
     
         34 . The composition according to  claim 32 , wherein none of the probiotic microorganisms in the composition have been propagated or grown in media containing gluten. 
     
     
         35 . The composition according to  claim 25 , wherein the pharmaceutically acceptable composition is labeled as a dietary supplement. 
     
     
         36 . The composition according to  claim 35 , wherein the pharmaceutically acceptable composition is in the form of a dried powder, a tablet, a hard gelatin capsule or a soft gelatin capsule. 
     
     
         37 . The composition according to  claim 36 , wherein the pharmaceutically acceptable composition is provided in a carrier material suitable for human consumption. 
     
     
         38 . The composition of  claim 37  wherein the carrier material is selected from the group consisting of: cereal based product, rice cake, soy cake, food bar product, cold formed food bar product, custard, pudding, gelatin, rice milk, soy milk, yogurt, kefir, mashed fruit product, candy, candy bar, and applesauce. 
     
     
         39 . The composition according to  claim 25 , wherein the composition further comprises at least one of an antibiotic agent or an antifungal agent. 
     
     
         40 . (canceled) 
     
     
         41 . The composition according to  claim 39 , wherein the antibiotic agent or antifungal agent is selected from the group consisting of: rifaximin, clarithromycin, azithromycin, amoxicillin, ampicillin, ciprofloxacin, vancomycin, metronidazole, nystatin, itraconazole, fluconazole, or a sulfonamide drug and mixtures thereof. 
     
     
         42 . The composition according to  claim 30 , wherein the pharmaceutically acceptable composition comprises about the following amounts of ingredients per serving or dose, where CFU means a Colony Forming Unit:
   Pediococcus acidilactici  1.5 billion CFU     Bifidobacterium breve  0.5 billion CFU     Bifidobacterium infantis  0.5 billion CFU     Lactobacillus paracasei  0.5 billion CFU     Lactobacillus salivarius  0.5 billion CFU     Bifidobacterium lactis  1.0 billion CFU     Bifidobacterium longum  1.0 billion CFU     Streptococcus thermophilus  1.0 billion CFU     Lactobacillus bulgaricus  1.0 billion CFU     Lactobacillus casei  2.5 billion CFU     Lactobacillus plantarum  2.5 billion CFU     Lactobacillus acidophilus  3.0 billion CFU     Bifidobacterium bifidum  3.5 billion CFU     Lactobacillus rhamnosus  6.0 billion CFU   
     
     
         43 . The composition according to  claim 42 , wherein the pharmaceutically acceptable composition further comprises at least one prebiotic agent that promotes the growth of probiotic microorganisms in the gastrointestinal tract. 
     
     
         44 . The composition of  claim 43  wherein the prebiotic agent comprises at least one of a fructooligosaccharide, galactooligosaccharide, lactulose, beta-glucan, inulin, pectin and resistant starch. 
     
     
         45 - 49 . (canceled) 
     
     
         50 . The pharmaceutical composition of  claim 25  further comprising another beneficial therapeutic agent selected from the group consisting of: proton pump inhibitors (PPIs) and H 2 -receptor antagonists. 
     
     
         51 - 52 . (canceled)