Method for diagnosing immunologic food sensitivity

Abstract

The invention includes novel methodology for diagnosing immunologic food or drug sensitivities. The method for diagnosing food sensitivities includes using diagnoses of other related disorders, such as microscopic colitis or other chronic immunologic/autoimmune syndromes, chronic diarrhea, irritable bowel syndrome, and hepatitis C and other hepatic diseases, Crohn's disease, alcoholism, and other idiopathic neuropsychiatric and neurologic disorders, as indicators in the diagnosis of the food sensitivety. Additionally, failure to respond to or a relapse after treatment for microscopic colitis with bismuth subsalicylate is disclosed by the present invention as being a further indicator in the diagnosis of immunologic food sensitivity. Finally, the presence of certain HLA-DQ alleles, particularly HLA-DQ1,3; -DQ1,7; -DQ1,8; and -DQ1,9, HLA-DQ1,1, and at least two subtypes of the HLA-DQ1 allele identified by molecular analysis as HLA-DQB1*0501 and HLA-DQB1*0602, as indicators in diagnosing immunologic food sensitivity, particularly gluten sensitivity or celiac sprue, and in diagnosing the related disease of microscopic colitis and other autoimmune disorders is also disclosed by the invention. A method for food sensitivity panel testing (for sensitivities other than gluten sensitivity) by detecting IgA antibodies in serum is also disclosed. A method for testing stool samples for the presence of particular antibodies, which is more sensitive and less invasive than prior art testing methods, is also disclosed for diagnosing immunologic food sensitivities. These methods of diagnosis may be used alone or in combination to further enhance the accuracy of diagnosis.

I claim:  
     
         1 . A method for diagnosing an immunologic food sensitivity comprising the steps of: 
 collecting a fecal sample;    screening the fecal sample to detect the presence of an antibody to a particular food substance; and    diagnosing an immunologic food sensitivity based on the presence of the antibody.    
     
     
         2 . The method of  claim 1  further comprising the step of concentrating the fecal sample to obtain a testing portion after said collecting step and wherein said testing portion is the sample in said screening step.  
     
     
         3 . The method of  claim 2  wherein the testing portion is undiluted.  
     
     
         4 . The method of  claim 2  further comprising the step of homogenizing the fecal sample prior to said concentrating step.  
     
     
         5 . The method of  claim 2  wherein the testing portion is about 20 grams.  
     
     
         6 . The method of  claim 1  wherein said screening step utilizes an enzyme-linked immunosorbant assay (ELISA) testing kit to detect the presence of an antibody to a particular food substance.  
     
     
         7 . The method of  claim 2  wherein said screening step utilizes an enzyme-linked immunosorbant assay (ELISA) testing kit to detect the presence of an antibody to a particular food substance.  
     
     
         8 . The method of  claim 2  wherein said concentrating step comprises the steps of: 
 centrifuging the fecal sample;  
 removing a supernatant portion from the centrifuged fecal sample; and  
 using the supernatant portion as the testing portion.  
 
     
     
         9 . The method of  claim 8  wherein the centrifuging step is performed at a rotation speed dependant upon the viscosity of the sample.  
     
     
         10 . The method of  claim 8  wherein tie rotation speed is between about 13,500 and 20,000 rpm.  
     
     
         11 . The method of  claim 8  wherein the testing portion is screened undiluted and is about equal to an amount of diluted serum required by standard use of an ELISA kit.  
     
     
         12 . The method of  claim 2  wherein said concentrating step comprises the steps of: 
 freeze-drying the fecal sample to a solid material; and  
 reconstituting the solid material with water to form a reconstituted testing portion.  
 
     
     
         13 . The method of  claim 12  wherein said reconstituted testing portion is about 25% solid material and about 75% water.  
     
     
         14 . The method of  claim 2  wherein said fecal sample contains more than about 90% water in its excreted state and wherein said concentrating step comprises the steps of: 
 freeze-drying the fecal sample to a solid material; and  
 reconstituting the solid material with water to form a reconstituted testing portion.  
 
     
     
         15 . The method of  claim 1  wherein the immunologic food sensitivity is gluten sensitivity or celiac sprue.  
     
     
         16 . The method of  claim 15  wherein the antibody is antigliadin IgA or antitissue transglutaminase IgA.  
     
     
         17 . The method of  claim 2  wherein the immunologic food sensitivity is gluten sensitivity or celiac sprue.  
     
     
         18 . The method of  claim 17  wherein the antibody is antigliadin IgA or antitissue transglutaminase IgA  
     
     
         19 . The method of  claim 1  wherein the immunologic food sensitivity is yeast sensitivity.  
     
     
         20 . The method of  claim 2  wherein the immunologic food sensitivity is yeast sensitivity.  
     
     
         21 . The method of  claim 19  wherein said yeast is  Saccharomyces cervesiae.    
     
     
         22 . The method of  claim 1  wherein the immunologic food sensitivity is milk sensitivity.  
     
     
         23 . The method of  claim 22  wherein the milk sensitivity is lactalbumin, casein, or bovine serum albumin sensitivity.  
     
     
         24 . The method of  claim 1  wherein immunologic food sensitivity is egg sensitivity.  
     
     
         25 . The method of  claim 24  wherein the egg sensitivity ovalbumin sensitivity.  
     
     
         26 . A method of diagnosing an immunologic food sensitivity comprising the step of detecting the presence of an HLA-DQ1,3 allele, a subtype of an HLA-DQ1,3 allele, an HLA-DQ1,1 allele, or a subtype of an HLA-DQ1 allele in a patient under diagnosis.  
     
     
         27 . The method of  claim 26  wherein the food sensitivity is gluten sensitivity or celiac sprue.  
     
     
         28 . The method of  claim 26  wherein said subtype of HLA-DQ1,3 is HLA-DQ1,7; HLA-DQ1,8; or HLA-DQ1,9.  
     
     
         29 . The method of  claim 26  wherein said subtype of HLA-DQ1 is HLA-DQB1*0501 or HLA-DQB1*0602.  
     
     
         30 . A method of diagnosing microscopic colitis comprising the step of detecting the presence of an HLA-DQ2 allele, an HLA-DQ8 allele, an HLA-DQ1,3 allele, a subtype of an HLA-DQ1,3 allele, an HLA-DQ1,1 allele, or a subtype of an HLA-DQ1 allele in a patient under diagnosis.  
     
     
         31 . The method of  claim 30  wherein said subtype of HLA-DQ 1,3 is HLA-DQ1,7; HLA-DQ1,8; or HLA-DQ1,9.  
     
     
         32 . The method of  claim 30  wherein said subtype of HLA-DQ1 is HLA-DQB1*0501 or HLA-DQB1*0602.  
     
     
         33 . A method of diagnosing an immunologic food sensitivity comprising the steps of: 
 identifying a patient at risk for immunologic food sensitivity;    collecting a bodily fluid sample or tissue sample;    screening the sample to detect the presence of an antibody to a particular food substance; and    diagnosing an immunologic food sensitivity based on the presence of the antibody.    
     
     
         34 . The method of  claim 33  wherein said identifying step comprises the step of diagnosing the patient with a disease or disorder related to an immunologic food sensitivity.  
     
     
         35 . The method of  claim 34  wherein said related disease or disorder presents similar symptoms as said immunologic food sensitivity.  
     
     
         36 . The method of  claim 35  wherein said symptoms are malabsorption of fluids, malabsorption of dietary nutrients, vitamin deficiency, osteoporosis, fatigue, anemia, diarrhea, weight loss, bloating, flatulence, abdominal pain, constipation, nausea, growth retardation in children, seizures, and other unexplained neurologic symptoms.  
     
     
         37 . The method of  claim 34  wherein said related disease or disorder is irritable bowel syndrome, microscopic colitis, chronic diarrhea, chronic liver disease, gastroesophageal reflux, hepatitis C, hepatic disease, Crohn's disease, an autoimmune disease, autism, alcoholism, idiopathic neurologic syndromes, or neuropsychiatric syndromes.  
     
     
         38 . The method of  claim 34  wherein said related disease or disorder has a genetic association with an HLA-DQ2; HLA-DQ8; HLA-DQ1,3; HLA-DQ1,7; HLA-DQ1,8; HLA-DQ1,9, HLA-DQ1,1, HLA-DQB1*0501 or HLA-DQB1*0602 allele.  
     
     
         39 . The method of  claim 33  wherein said identifying step comprises detecting the presence of an HLA-DQ1,3 or a subtype of an HLQ-DQ1,3 allele in the patient.  
     
     
         40 . The method of  claim 39  wherein said subtype is HLA-DQ1,7; HLA-DQ1,8; or HLA-DQ1,9.  
     
     
         41 . The method of  claim 33  wherein said screening step utilizes an enzyme-linked immunosorbant assay (ELISA) testing kit to detect the presence of an antibody to a particular food substance.  
     
     
         42 . The method of  claim 34  wherein said screening step utilizes an enzyme-linked immunosorbant assay (ELISA) testing kit to detect the presence of an antibody to a particular food substance  
     
     
         43 . The method of  claim 33  wherein said sample is a fecal sample.  
     
     
         44 . The method of  claim 43  further comprising the step of concentrating said fecal sample to obtain a testing portion prior to said screening step and wherein said testing portion is the sample in said screening step.  
     
     
         45 . The method of  claim 44  further comprising the step of homogenizing the fecal sample prior to concentrating said sample.  
     
     
         46 . The method of  claim 44  wherein the testing portion is screened undiluted and is about equal to an amount of diluted serum required by standard use of an ELISA kit.  
     
     
         47 . The method of  claim 33  wherein the immunologic food sensitivity is gluten or celiac sprue.  
     
     
         48 . The method of  claim 47  wherein the antibody is antigliadin IgA or antitissue transglutaminase IgA.  
     
     
         49 . A method for diagnosing an immunologic drug sensitivity comprising the steps of: 
 collecting a fecal sample;    screening the fecal sample to detect the presence of an antibody to a particular drug substance; and    diagnosing an immunologic drug sensitivity based on the presence of the antibody.    
     
     
         50 . The method of  claim 49  further comprising the step of concentrating the fecal sample to obtain a testing portion prior to said screening step and wherein said testing portion is the sample in said screening step.  
     
     
         51 . The method of  claim 50  wherein said screening step utilizes an enzyme-linked immunosorbant assay (ELISA) testing kit to detect the presence of an antibody to a particular drug substance.  
     
     
         52 . The method of  claim 50  wherein said concentrating step comprises the steps of: 
 centrifuging the fecal sample;  
 removing a supernatant portion from the centrifuged fecal sample; and  
 using the supernatant portion as the testing portion.  
 
     
     
         53 . The method of  claim 50  wherein the testing portion is screened undiluted and is about equal to an amount of diluted serum required by standard use of an ELISA kit.  
     
     
         54 . The method of  claim 50  wherein said concentrating step comprises the steps of: 
 freeze-drying the fecal sample to a solid material; and  
 reconstituting the solid material with water to form a reconstituted testing portion.  
 
     
     
         55 . A method of diagnosing an immunologic food sensitivity comprising the steps of: 
 diagnosing a patient with microscopic colitis;    treating the patient's microscopic colitis with bismuth subsalicylate;    diagnosing an immunologic food sensitivity if the patient's microscopic colitis does not respond to the bismuth subsalicylate treatment or if the patient's microscopic colitis relapses after treatment.    
     
     
         56 . The method of  claim 55  further comprising the following steps: 
 collecting a fecal sample;  
 screening the fecal sample to detect the presence of an antibody to a particular food substance; and  
 confirming diagnosis of an immunologic food sensitivity based on the presence of the antibody.  
 
     
     
         57 . The method of  claim 56  further comprising the step of concentrating the fecal sample to obtain a testing portion and wherein said testing portion is the sample in said screening step.  
     
     
         58 . The method of  claim 57  further comprising the step of homogenizing the fecal sample prior to concentrating said sample.  
     
     
         59 . The method of  claim 56  wherein said screening step utilizes an enzyme-linked immunosorbant assay (ELISA) testing kit to detect the presence of an antibody to a particular food substance.  
     
     
         60 . The method of  claim 57  wherein said concentrating step comprises the steps of: 
 centrifuging the fecal sample;  
 removing a supernatant portion from the centrifuged fecal sample; and  
 using the supernatant portion as the testing portion.  
 
     
     
         61 . The method of  claim 57  wherein the testing portion is screened undiluted and is about equal to an amount of diluted serum required by standard use of an ELISA kit.  
     
     
         62 . The method of  claim 57  wherein said concentrating step comprises the steps of: 
 freeze-drying the fecal sample to a solid material; and  
 reconstituting the solid material with water to form a reconstituted testing portion.  
 
     
     
         63 . The method of  claim 55  wherein the immunologic food sensitivity is gluten sensitivity or celiac sprue.  
     
     
         64 . The method of  claim 63  wherein the antibody is antigliadin IgA or antitissue transglutaminase IgA.