Crohn's disease diagnostic and treatment methods and compositions

Abstract

A composition and method for detecting Crohn's disease include the use of serological testing as a rapid and simple way to diagnose Crohn's disease. The serological tests were based on the use of the two recombinant clones isolated from an M. paratuberculosis genomic library that expressed 35K and 36K MW antigens. Antigen p35 was isolated from Johne's disease sera (acid-fast bacilli form) and p36, from human CD sera (spheroplast form). The combined use of p35 and p36 recombinant antigens provides a highly specific and sensitive test to demonstrate the humoral immune response of CD patients to M. paratuberculosis. A serologic kit is disclosed including the composition including the combined p35 and p36 antigens. A treatment methodology utilizes antimycobacterial drugs, preferably upon patients prescreened for the presence of M para. A particular antibiotic regimen includes an administration of both rifabutin and clarithromycin, which has been found to be particularly effective in alleviating the symptoms of Crohn's disease.

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