Methods and Compositions for the Prevention and Treatment of Influenza

Abstract

This disclosure relates to the prevention and treatment of Influenza, and more particularly Influenza A Virus Subtype H1N1, with the use of a pharmaceutical composition comprising one or more digestive enzymes, such as pancreatic enzymes and porcine pancreatic enzymes. The disclosure further relates to the use of an individual's fecal chymotrypsin level as an indicator, e.g., biomarker of whether an individual may be more susceptible to Influenza, e.g., Influenza A Subtype H1N1, and/or whether an individual will benefit from administration of the described pharmaceutical compositions. Use of the compositions as sanitizers, antiseptics, disinfectants, and detergents, e.g., to reduce or eradicate influenza virus present on living or inanimate surfaces is also contemplated.

What is claimed is: 
     
         1 . A method for the treatment or prevention of Influenza in a mammal or a bird, comprising administering to the mammal or bird a therapeutically effective amount of a pharmaceutical composition comprising one or more digestive enzymes. 
     
     
         2 . The method of  claim 1  wherein the Influenza is Influenza Type A. 
     
     
         3 . The method of  claim 2  where the Influenza Type is Subtype H1N1. 
     
     
         4 . The method of  claim 1  wherein the one or more digestive enzymes comprise one or more enzymes selected from the group consisting of proteases, amylases, celluloses, sucrases, maltases, papain, and lipases. 
     
     
         5 . The method of  claim 1  wherein the one or more digestive enzymes comprise one or more pancreatic enzymes. 
     
     
         6 . The method of  claim 1  wherein the one or more of the digestive enzymes comprise avian enzymes or pig enzymes. 
     
     
         7 . The method of  claim 4  wherein the proteases comprise chymotrypsin and trypsin. 
     
     
         8 . The method of  claim 1  wherein the one or more digestive enzymes are, independently, derived from an animal source, a microbial source, a plant source, a fungal source, or are synthetically prepared. 
     
     
         9 . The method of  claim 1  wherein the mammal is a pig, horse, cow, dog, cat, monkey, rat, mouse, sheep, goat or human. 
     
     
         10 . The method of  claim 8  where the animal source is a pig pancreas. 
     
     
         11 . The method of  claim 1  wherein the pharmaceutical composition comprises at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, and at least one lipase. 
     
     
         12 . The method of  claim 1 , further comprising vaccinating the mammal or bird with a TIV or LAIV, or treating the mammal or bird with an anti-viral medication, or both. 
     
     
         13 . The method of  claim 1  wherein the pharmaceutical composition comprises: amylases from about 10,000 to about 60,000 U.S.P, proteases from about 10,000 to about 70,000 U.S.P, lipases from about 4,000 to about 30,000 U.S.P., chymotrypsin from about 2 to about 5 mg, trypsin from about 60 to about 100 mg, papain from about 3,000 to about 10,000 USP units, and papaya from about 30 to about 60 mg. 
     
     
         14 . The method of  claim 1  wherein the pharmaceutical composition comprises at least one protease and at least one lipase, and wherein the ratio of total proteases to total lipases (in USP units) ranges from about 1:1 to about 20:1. 
     
     
         15 . The method of  claim 11  wherein the ratio of proteases to lipases ranges from about 4:1 to about 10:1. 
     
     
         16 . The method of  claim 1  wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of: pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof. 
     
     
         17 . A method of diagnosing a patient as immune-compromised comprising:
 a. obtaining a fecal sample from the patient;   b. determining a level of chymotrypsin present in the fecal sample; and   c. diagnosing the patient as having a compromised immune system if the determined fecal chymotrypsin level is less than a control level.   
     
     
         18 . The method of  claim 17  wherein the determined fecal chymotrypsin level is less than 8.4 U/gram. 
     
     
         19 . The method of  claim 17  wherein the determined fecal chymotrypsin level is less than 4.2 U/gram. 
     
     
         20 . The method of  claim 17  wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method. 
     
     
         21 . The method of  claim 17  further comprising administering to the patient an effective amount of a pharmaceutical composition comprising one or more digestive enzymes if the patient is diagnosed as having a compromised immune system. 
     
     
         22 . The method of  claim 21  further comprising determining if the administration of the pharmaceutical composition reduces or ameliorates the propensity or frequency of contracting bacterial or viral illnesses or the severity of bacterial or viral illnesses. 
     
     
         23 . The method of  claim 22  further comprising comparing the post-administration measurement of one or more symptoms of the illness to a pre-administration measurement of the one or more symptoms of illness. 
     
     
         24 . A method of identifying a patient likely to benefit from administration of a pharmaceutical composition comprising one or more digestive enzymes comprising:
 obtaining a fecal sample from the patient;   determining a level of chymotrypsin present in the fecal sample; and   identifying the patient as likely to benefit from administration of the pharmaceutical composition if the determined fecal chymotrypsin level is less than a control level and the patient is diagnosed with a compromised immune system or the patient is exhibiting one or more symptoms associated with a bacterial or viral illness.   
     
     
         25 . The method of  claim 24  further comprising determining if the patient exhibits one or more symptoms of a compromised immune system. 
     
     
         26 . The method of  claim 24  wherein the benefit comprises a reduction or amelioration of one or more symptoms associated with a bacterial or viral illness. 
     
     
         27 . The method of  claim 24  wherein the level of chymotrypsin present in the fecal sample is determined using an enzymatic photospectrometry method. 
     
     
         28 . The method of  claim 24  further comprising administering to the patient an effective amount of a pharmaceutical composition comprising one or more digestive enzymes. 
     
     
         29 . A pharmaceutical composition comprising one or more digestive enzymes, wherein the one or more digestive enzymes comprise at least one lipase and at least one protease, and wherein the ratio of total proteases to total lipases (in USP units) ranges from about 1:1 to about 20:1. 
     
     
         30 . The pharmaceutical composition of  claim 29  wherein the ratio of total proteases to total lipases ranges from about 4:1 to about 10:1. 
     
     
         31 . A pharmaceutical composition comprising at least one amylase, a mixture of proteases comprising chymotrypsin and trypsin, and at least one lipase. 
     
     
         32 . The pharmaceutical composition of  claim 31  wherein the pharmaceutical composition further comprises papain. 
     
     
         33 . The pharmaceutical composition of  claim 29  or  31  wherein the pharmaceutical composition is lipid encapsulated. 
     
     
         34 . A method for treating a mammal or bird exhibiting one or more symptoms of Influenza comprising administering to the mammal or bird a therapeutically effective amount of a composition comprising one or more digestive enzymes. 
     
     
         35 . The method of  claim 34  where the symptoms of influenza are selected from the group consisting of: fever, headache, tiredness, cough, sore throat, runny or stuffy nose, body aches, diarrhea and vomiting, and a combination thereof. 
     
     
         36 . The method of  claim 34  wherein the mammal is a human or a pig. 
     
     
         37 . The method of  claim 34  wherein the preparation is administered orally via a dosage formulation selected from the group consisting of: emulsions, liquids, pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, powders, sprinkles, and a combination thereof. 
     
     
         38 . A method of preventing infection of an individual with Influenza or of treating an individual diagnosed with Influenza comprising:
 measuring a level of fecal chymotrypsin in a stool sample of the individual;   comparing the level of fecal chymotrypsin with a normal fecal chymotrypsin level;   and administering a composition comprising one or more digestive enzymes to the individual if the level of fecal chymotrypsin in the individual is less than a normal fecal chymotrypsin level.   
     
     
         39 . A method for sanitizing or disinfecting a surface to reduce the amount of influenza virus thereon or to eradicate the influenza virus thereon, comprising applying to the surface a composition comprising one or more digestive enzymes. 
     
     
         40 . A method for reducing the amount of influenza virus present on a skin region, tissue, or wound of a mammal or bird comprising applying to the skin region, tissue, or wound a composition comprising one or more digestive enzymes.