Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Reexamination Certificate
2001-03-02
2003-12-23
Nguyen, Bao-Thuy L. (Department: 1641)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
C435S007100, C435S007900, C435S007940, C435S007930, C435S971000, C436S513000, C436S514000, C436S518000, C436S811000
Reexamination Certificate
active
06667160
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The invention relates to diagnosing immunologic food or drug sensitivities and their related intestinal diseases or disorders and noninvasive testing for such. In particular, the invention relates to a method for diagnosing immunologic food sensitivity by testing stool for the presence of antibodies. The invention also relates to identifying immunologic food sensitivities, and their related intestinal diseases or disorders, based on the presence of IgA antibodies in blood, the presence of certain other related disorders or diseases, the presence of certain HLA alleles, or based on failure to respond to bismuth subsalicylate treatment of microscopic colitis or a relapse of microscopic colitis after bismuth subsalicylate treatment.
BACKGROUND OF THE INVENTION
Persons with a variety of immunologic food or drug sensitivities, and related intestinal diseases or disorders, may experience a number of ill effects when a particular food or drug substance, or ingredient in the food or drug, is ingested. The ill effects from an allergy (also called immediate or type I hypersensitivity) to a particular food or drug substance or ingredient usually causes rapid development of symptoms including shortness of breath, hives, swelling of the mouth and throat, and sometimes abdominal pain and diarrhea. This form of food allergy traditionally has been diagnosed by skin testing or by measuring IgE antibodies in the blood directed against the food in question. However, chronic immunologic sensitivity to a food involving T and B lymphocytes as part of the chronic cell mediated immune system (also called delayed or type IV hypersensitivity) may include overt symptoms such as abdominal pain, diarrhea, constipation, and weight loss, and may also include less noticeable effects stemming from malabsorption of fluids and dietary nutrients, such as osteoporosis, anemia, or vitamin deficiencies. Without proper diagnostic testing, which currently is limited to invasive means such as blood or serum testing or endoscopic intestinal biopsy, a person may not realize that he or she has an immunologic food sensitivity or immunologic drug sensitivity and may unknowingly continue to consume the triggering food or drug, which may have long term health implications.
For purposes of this background description, the summary of the invention, and the claims no distinction is drawn between an immunologic food or drug sensitivity and the related intestinal disease or disorder stemming from the immune system's reaction to the food or drug ingredient and they are collectively referred to as an immunologic food sensitivity or immunologic drug sensitivity. The description provided is primarily related to immunologic food sensitivities, but it is recognized that certain drugs or ingredients in drugs also trigger immunologic reactions creating an immunologic drug sensitivity similar to such a food sensitivity.
One such immunologic food sensitivity is gluten sensitivity, or more severely, the intestinal disease celiac sprue. Celiac sprue results from an immunologic reaction to dietary gluten contained in wheat, barley, rye, and oats, that results in any degree of intestinal histopathology. By current definitions and classic descriptions, the gluten-induced immunologic process causes villous atrophy and inflammation of the small intestine, in turn, resulting in diarrhea and weight loss from malabsorption of fluid, electrolytes, and dietary nutrients. Despite the fact that chronic diarrhea is the most common symptom of celiac sprue in its classic, villous atrophic, form, there have been no studies of the prevalence of celiac sprue or other immunologic food sensitivities in patients presenting to physicians with chronic diarrhea or other common gastrointestinal symptoms. Additionally, there are no adequate methods in the prior art to diagnose or noninvasively test for immunologic food sensitivities when the patient presents with little or no common gastrointestinal symptoms or when the symptoms are also attributable to other diseases. This frequently results in either no diagnosis or the missed diagnosis of an immunologic food sensitivity.
In recent years it has been discovered that many if not most individuals with celiac sprue do not have diarrhea or weight loss, but instead have other signs and symptoms such as vague abdominal pain, nausea, chronic fatigue, constipation, growth retardation of children, iron deficiency anemia, osteoporosis, seizures or other neurologic disorders, or elevated liver enzyme levels in serum. Some patients may have no signs or symptoms whatsoever.
Furthermore, patients with gluten sensitivity may not have the fully developed intestinal lesion associated with celiac sprue, instead possessing minimally inflamed or even normal small intestinal histology. Therefore, the immunologic food sensitivity of these patients may not be properly diagnosed using known testing methods, such as endoscopic intestinal biopsy and blood or serum testing. Additionally, these patients may present with other immunologic diseases such as autoimmune diseases of skin, liver, joints, kidneys, pancreas, and/or thyroid among others, microscopic colitis, or hepatitis C-induced liver disease, which according to known methodologies has furthered the misdiagnosis of immunologic food sensitivities in the past. However, the exact prevalence of gluten sensitivity or celiac sprue in patients presenting with these immune disorders is unknown, and the full spectrum of such gluten sensitivity, particularly that with fewer classic features, is not adequately addressed in the prior art.
Traditionally, celiac sprue has been regarded as a severe malabsorptive condition of the small intestine that presents clinically mainly with diarrhea and significant weight loss. Although in the U.S. this concept of the disease is still widely held, in Europe it has become recognized that celiac sprue does not always present in traditional fashion, but instead may manifest with mild gastrointestinal or constitutional symptomatology, or asymptomatically in association with other disorders as mentioned above. For this reason, European physicians, especially those in geographic areas where celiac sprue has been thought to be endemic, such as Ireland, U.K., Italy, and Scandinavia, have had a higher diagnostic index of suspicion of celiac sprue in their patients than American physicians have had, and consequently diagnose more cases than traditionally has been done in American institutions. Moreover, in several screening studies of normal subpopulations of these European countries, the disease prevalence of celiac sprue has averaged about 400 per 100,000 population (1 in 250 persons).
By comparison, from limited retrospective information from a single U.S. quaternary care referral center, celiac sprue was calculated to have a prevalence of 22 per 100,000 (1 in 4000-5000) among the American population. However, a group of 2000 blood donors from the U.S. displayed a serologic pattern suggestive of celiac sprue with a frequency of 1 in 250, similar to the prevalence of the disease in European studies. Although, these blood donors were not evaluated clinically, so that the diagnosis of celiac sprue was not formally confirmed, these results suggest that celiac sprue may be present in a large number of undiagnosed Americans. Moreover, serologic data from 228 individuals from a shopping mall were screened by Applicant for celiac sprue. This screening revealed one individual with both antigliadin and anti-tissue transglutaminase antibodies, which are known indicators of gluten sensitivity or celiac sprue, who was subsequently found by small intestinal biopsy to have a mild lesion of celiac sprue, and 28 others with antigliadin antibodies, without anti-tissue transglutaminase antibodies, which is indicative of gluten sensitivity, but not the more severe celiac sprue. Over 40% of these latter 28 patients had steatorrhea and mild small intestinal inflammation. These data indicate that the prevalence of celiac sprue in the general U.S. pop
Barnes Robin L.
Nguyen Bao-Thuy L.
Storm & Hemingway L.L.P.
LandOfFree
Method for diagnosing immunologic food sensitivity does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method for diagnosing immunologic food sensitivity, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method for diagnosing immunologic food sensitivity will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3156057