Materials and methods for treatment and diagnosis of disorders associated with oxidative stress

Abstract

The subject invention pertains to materials and methods for the prevention and treatment of disease conditions associated with oxidative stress or a compromised reducing environment, including inflammatory bowel diseases such as ulcerative colitis. Another aspect of the subject invention concerns compositions formulated for administration as an enema. The subject invention also concerns compositions formulated for oral administration. Methods of the invention include administration of compounds or compositions of the invention. In one embodiment, compounds or compositions of the invention are rectally instilled in a patient. In another embodiment, compounds or compositions are orally administered.

I claim: 
     
         1 . A composition formulated for rectal administration as an enema or suppository in a person or animal, said composition comprising an aminosalicylic acid and a steroid. 
     
     
         2 . The composition according to  claim 1 , wherein said aminosalicylic acid is 5-ASA, or 4-ASA, or an analog or derivative of an aminosalicylic acid. 
     
     
         3 . The composition according to  claim 1 , wherein said composition further comprises an emulsifying agent and/or a mast cell stabilizer. 
     
     
         4 . The composition according to  claim 3 , wherein said emulsifying agent is polysorbate-80. 
     
     
         5 . The composition according to  claim 3 , wherein said mast cell stabilizer is cromolyn sodium or nedocromil sodium. 
     
     
         6 . The composition according to  claim 1 , wherein said composition comprises from about 500 mg to about 5000 mg of 5-ASA; or from about 750 mg to about 3000 mg of 5-ASA; or about 2000 mg of 5-ASA. 
     
     
         7 . The composition according to  claim 1 , wherein said steroid is a corticosteroid. 
     
     
         8 . The composition according to  claim 1 , wherein said steroid is hydrocortisone, prednisone, prednisolone, betamethasone, beclometasone, tixocortol, or budesonide, or an analog or derivative thereof. 
     
     
         9 . The composition according to  claim 1 , wherein said composition further comprises a short chain fatty acid. 
     
     
         10 . The composition according to  claim 9 , wherein said fatty acid is sodium butyrate, proprionate, or acetate. 
     
     
         11 . The composition according to  claim 10 , wherein said composition comprises about 5 to about 50 millimoles of sodium butyrate; or about 15 millimoles of sodium butyrate. 
     
     
         12 . The composition according to  claim 1 , wherein said composition comprises from about 1 mg to about 10 mg of budesonide; or from about 2.5 mg to about 7.5 mg of budesonide; or about 5 mg of budesonide. 
     
     
         13 . The composition according to  claim 5 , wherein said composition comprises about 10 to about 1000 mg of cromolyn sodium; or about 100 mg of cromolyn sodium. 
     
     
         14 . The composition according to  claim 1 , wherein said composition comprises 5-ASA, or an analog or derivative thereof; budesonide; and cromolyn sodium. 
     
     
         15 . The composition according to  claim 14 , wherein said composition further comprises sodium butyrate. 
     
     
         16 . A composition formulated for oral administration to a person or animal, said composition comprising alpha-lipoic acid, and/or N-acetyl-L-cysteine (N-A-C), and/or L-glutamine. 
     
     
         17 . The composition according to  claim 16 , wherein said composition further comprises 5-ASA. 
     
     
         18 . The composition according to  claim 16 , wherein said composition further comprises a compound that inhibits tissue necrosis factor (TNF). 
     
     
         19 . The composition according to  claim 18 , wherein said compound that inhibits TNF is selected from the group consisting of resveratrol, stinging nettle leaf extract, and berberine. 
     
     
         20 . The composition according to  claim 16 , wherein said composition further comprises one or more compounds selected from the group consisting of a composition that directly neutralizes H 2 O 2 , a composition that helps protect proteins from oxidation and/or degradation, and a composition that protects nucleic acids.