Compositions and methods for assessing gastrointestinal health

Abstract

The present invention relates to kits designed for the collection of stool samples and methods of analyzing those samples for biological markers of maldigestion, inflammation, and imbalanced gut flora.

What is claimed is: 
     
         1 . A method of assessing a patient's gastrointestinal health, the method comprising:
 (a) providing a stool sample from the patient; and   (b) subjecting the sample to three tests: a first test for maldigestion, a second test for inflammation, and a third test for gut flora.   
     
     
         2 . The method of  claim 1 , wherein the first test for maldigestion comprises testing for pancreatic insufficiency. 
     
     
         3 . The method of  claim 2 , wherein the testing for pancreatic insufficiency comprises evaluating the amount of a pancreatic elastase (PE), or a heterologous protein that is co-regulated with PE, in the stool sample. 
     
     
         4 . The method of  claim 3 , wherein the PE is the isozyme pancreatic elastase 1 (PE1). 
     
     
         5 . The method of  claim 4 , wherein an amount of PE1 that is more than about 200 μg, but less than about 350 μg, per gram of stool, indicates mild pancreatic insufficiency. 
     
     
         6 . The method of  claim 4 , wherein an amount of PE1 that is more than about 100 μg, but less than about 200 μg, per gram of stool, indicates moderate pancreatic insufficiency. 
     
     
         7 . The method of  claim 4 , wherein an amount of PE1 that is less than about 100 μg per gram of stool indicates severe pancreatic insufficiency. 
     
     
         8 . The method of  claim 6 , further comprising testing for intestinal permeability, generating a comprehensive parasitology profile, and/or testing for Celiac disease. 
     
     
         9 . The method of  claim 7 , further comprising an assessment of bone resorption, analysis of glucose and/or insulin levels, testing for Celiac disease, and/or testing for bacterial overgrowth in the small intestine. 
     
     
         10 . The method of  claim 1 , wherein the second test for inflammation comprises testing for calprotectin or occult blood in the stool sample. 
     
     
         11 . The method of  claim 10 , wherein the testing for calprotectin comprises evaluating the amount of calprotectin, or a heterologous protein that is co-regulated with calprotectin, in the stool sample. 
     
     
         12 . The method of  claim 11 , wherein the amount of calprotectin is elevated to about 50-120 μg per gram of stool, indicating low-grade inflammation of the gastrointestinal tract. 
     
     
         13 . The method of  claim 11 , wherein the amount of calprotectin is elevated to more than about 120 μg per gram of stool, indicating significant inflammation in the gastrointestinal tract. 
     
     
         14 . The method of  claim 11 , wherein the amount of calprotectin is elevated to more than about 250 μg per gram of stool, indicating severe inflammation in the gastrointestinal tract and that patients with inflammatory bowel disease are at high risk of relapse within one year. 
     
     
         15 . The method of  claim 12 , wherein testing for inflammation is repeated in about six weeks. 
     
     
         16 . The method of  claim 11 , further comprising assessing intestinal permeability, testing for food allergies, and/or performing a comprehensive parasitology profile. 
     
     
         17 . The method of  claim 1 , wherein the gut flora is harmful gut flora. 
     
     
         18 . The method of  claim 17 , wherein testing for harmful gut flora comprises testing the stool sample for the presence of  Clostridium difficile, Cryptosporidium, Giardia lamblia, Enamoeba histolytica, Blastocystis hominis , and/or  Helicobactor pylori.    
     
     
         19 . The method of  claim 17 , further comprising testing for beneficial gut flora. 
     
     
         20 . The method of  claim 19 , wherein testing for beneficial gut flora comprises testing the stool sample for the presence of lactobacilli,  bifidobacteria , and/or  Escherichia coli.    
     
     
         21 . A kit for the collection of a stool sample, the kit comprising
 (a) a collection tub;   (b) a tube containing a fixative medium;   (c) a tube containing a medium that maintains the relative proportions of organisms in a stool sample; and   (d) written materials.   
     
     
         22 . The kit of  claim 21 , wherein the written materials comprise one or more of:
 (a) instructions for use;   (b) a requisition form; and   (c) a mailing envelope.   
     
     
         23 . The kit of  claim 21 , further comprising one or more of the following items:
 (a) a holder to suspend the collection tub over a toilet;   (b) an empty cup;   (c) an absorbent pad;   (d) a flat tool suitable for insertion into a hand-held tube; and   (e) a glove.