Diagnostic method for establishing food intolerance/allergy, and

Surgery – Miscellaneous – Methods

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436513, A61B 1900, G01N 33558

Patent

active

059838990

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to a novel method of diagnosing allergies, in particular food intolerances/allergies, and is based on the analysis of inflammation mediators (markers) that are released in the large intestine after provocation of the mucous membrane of the large intestine by the allergen. The invention also relates to a novel instrument that can be used for this type of diagnosis to provoke the mucous membrane in the large intestine. According to preferred embodiments, the instrument can be used to collect released mediators (markers) at the same time as provoking the mucous membrane.
The expression allergen in connection with the present invention is linked to discomfort in form of food intolerance/allergy. The expression is thus not imperatively linked to the discomfort being IgE mediated.
By large intestine is meant the colon and the rectum.


KNOWN TECHNIQUES OF DIAGNOSING FOOD INTOLERANCE/ALLERGY AND ASSOCIATED
PROBLEMS
Present methods of diagnosing suspected food intolerance/allergy either have a limited value and/or are time-consuming. In the case of gluten intolerance, the methods are based on establishing villus atrophy in the small intestine and that the villus atrophy reverses when gluten is excluded from the diet. A guideline in this respect is found in the presence of serum antibodies against gluten. The diagnostic methods are highly deficient in respect of other forms of food intolerance/allergies. It is known from biopsy studies that gluten ingestion promotes a local inflammatory reaction in the small intestine, although there is no detailed understanding of the process. In earlier works, endeavours have been made to study the local inflammatory response of patients suffering from coeliac disease, by continuous perfusion of small intestine that has been provoked by gluten. The results show the development of a slight but significant response (B. Lavo, et al, Gut 31 (1990) 153-7; B. Lavo, et al, Am. J. Med. 87 (1989) 655-60; B. Lavo, et al, Gastroenterology 99 (1990) 703-7). The performance of small intestine perfusion, however, is technically demanding and arduous and is unsuitable for clinical diagnosis in practice.
The rectal provocation of patients suffering from coeliac disease in combination with biopsy studies has earlier been described (Dobbins, et al, Gastroenterology 47 (1964) 471-9; Austin, et al, Gut 29 (1988) 200-5; Loft, et al, Gastroenterology 97 (1989) 29-37 and Loft, et al, Lancet 335 (1990) 1293-5).
Studies have also been carried out on the basal, i.e. unprovoked, release of inflammatory mediators of patients suffering from ulcerative colitis, proctitis, Crohn's disease and other unspecified colon diseases (Y. Raab, et al, Am. J. Gastroenterology 87 (1992) 1453-9; Y. Raab, et al, Gut 34 (1993) 1203-6; and Y. Raab, et al, Digestions 55 (1994) 44-9). Samples were taken by segmental perfusion of colon and rectum. The studies were made possible with the aid of a catheter applied in the colo-rectal part of the intestine (Krog, et al, WO-A 9108013). It is alleged that the catheter concerned has a provocative function, although the method and the purpose of this provocation has not been defined.
There is thus an urgent need for a test system which will enable food intolerance/allergy to specific food substances to be established in a simple, quick and positive fashion.


BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a known instrument (catheter) that can be used in conjunction with the invention (Krog, et al, WO-A-9108013).
FIGS. 2a and b illustrate a further embodiment of the known instrument (catheter) and also include a sectioned view of that part which is intended to hold the instrument in place in the intestine (Krog, et al, WO-A-9108013).
FIG. 3 shows the instrument in FIG. 1 (Krog, et al, WO-A-9108013) applied in the large intestine for provocation with the allergen and/or collection of released markers.
FIGS. 4a, b and c illustrate an embodiment of the inventive instrument.
FIG. 5 shows the instrument of FIG. 4 applied in the rectum.
Those parts which

REFERENCES:
patent: 5312343 (1994-05-01), Krog et al.
Allergy, vol. 44, No. 8, 1989, Nolte et al: Comparison of Intestinal Mast Cell and Basophil Histamines Release in Children With Food Allergic Reactions pp. 554-565.
Derwent's Abstract, No. 88-320634/45, week 8845, Abstract of Su, 1389759 (Ryazan Med Inst), Apr. 23, 1988.

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