Crohn's Disease Clinical Trial
Official title:
Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease in Populations of High vs. Low Tuberculosis Endemicity
One aims to devise a method for the screening and differentiation of intestinal tuberculosis and Crohn's Disease. Additionally, one aims to detect and survey multidrug resistant TB.
Intestinal tuberculosis (ITB) and Crohn's disease (CD) may present identically; the
consequence of misdiagnosing and mistreating one disease for the other may be grave. CD is
on the increase worldwide while TB re-emerges in areas of low TB endemicity. Current
diagnostic guidelines evolve from research in areas with low TB prevalence, thereby being
inappropriate in TB endemic regions. To date, no simple or non-invasive methods exist to
diagnose ITB and to differentiate it from CD.
One aims to devise a method for screening and differentiation of the two diseases. By using
non-invasive rapid tests one wishes to make diagnostics available to resource poor settings.
Ideally, referrals to invasive diagnostic procedures would decrease, thus liberating
economic and staff resources. Furthermore, patients may avoid unnecessary, expensive and
often inconclusive advanced procedures. Additionally, one aims to detect and survey
multidrug resistance caused by empiric TB treatment, which in itself obscures ITB diagnosis.
This case control study matches 50 ITB patients and 50 CD patients with 100 healthy controls
in India, and 50 CD patients with 100 healthy controls in Norway. Comparative statistical
analysis will be carried out. Challenges include patient adherence and sample handling.
Non-TB gastrointestinal infections may confound the results and will be adjusted for.
Recently published data suggests that the serum/faecal calprotectin ratio may be used to
discriminate ITB from healthy subjects.
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Observational Model: Case Control, Time Perspective: Prospective
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