Method for diagnosing lactose intolerance and diagnostic kit...

Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – In an organic compound

Reexamination Certificate

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C424S001110, C424S001650, C424S009100, C424S009200, C424S001730

Reexamination Certificate

active

07037487

ABSTRACT:
The method for diagnosing lactose intolerance in patients by the oral administration of defined amounts of lactose, followed by assaying metabolites of lactose, is performed in a way where the lactose administered contains 99%13C-labeled lactose, preferably from 5 to 30 mg, and after the administration of the lactose, the content of13C-labeled lactose is determined in a serum sample taken at a defined time after the administration. A diagnostic kit for performing the method consists of a capsule with from 5 to 30 mg of 99%13C-labeled lactose, a patient instruction manual, a blood sampling device, sample containers for collecting the blood sample, and optionally a spatula and sample container for a stool specimen.

REFERENCES:
patent: 5640014 (1997-06-01), Sauke et al.
Peuhkuri et al., “Wide variations of the testing of lactose tolerance: results of a questionnaire study in Finnish health care centres”, XP-001027414,Scandinavian Journal of Clinical and Laboratory Investigation,vol. 60, No. 4, (Jul. 2000), p. 291-298.
Hiele et al., “ Carbon-13 Dioxide Breath Test Using Naturally Carbon-13-Enriched Lactose for Detection of Lactase Deficiency in Patients with Gastrointestinal Symptoms”, XP-00102178,Journal of Laboratory and Clinical Medicine,vol. 112, No. 2, (1988), pp. 193-200.
Murray et al., “Comparative Absorption of Carbon-13 Glucose and Carbon-13 Lactose by Premature Infants”, XP-001027415,American Journal of clinical Nutrition,vol. 51, No. 1, (1990), pp. 59-66.
Hermans et al., “The Relationship Between Lactose Tolerance Test Results and symptoms of Lactose Intolerance”, XP-001027136,American Journal of Gastroenterology,vol. 92, No. 6, (1997), pp. 981-984.
Vonk Roel et al., “Small Intestinal and Colonic Factors Involved in Lactose Intolerance”, XP-001027262,FASEB Journal,vol. 15, No. 4, (Mar. 2001), pp. p. A277,Annual Meeting of the Federation of American Societies for Experimental Biology on Experimental Biology 2001.
Vonk et al., The 13C/2H-Glucose Test For Determination of Small Intestinal Lactase Activity, XP-000998471,European Journal of Clinical Investigations,vol. 31, No. 3, (2001), pp. 226-233.

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