Status:
UNKNOWN
Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease
Lead Sponsor:
Lovisenberg Diakonale Hospital
Collaborating Sponsors:
Helse Sor-Ost
The Unger-Vetlesen Medical Fund, Jersey, C.I
Conditions:
Intestinal Tuberculosis
Pulmonary Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Above 18 years of age.
- ITB as per standard criteria a), and one or more of b) to e) must be fulfilled (Gold standard):
- Endoscopic apparent intestinal tuberculosis: transverse ulcers, pseudopolyps, involvement of fewer than four intestinal segments, patulous ileo-coecal valve
- Histological evidence of tubercles/granulomas with caseation necrosis in intestinal biopsies
- DNA of M.tb detected by PCR of intestinal biopsies
- Positive immunohistochemistry in intestinal biopsies.
- Histological demonstration of acid fast bacilli in a lesion.
- Active Crohn's disease as per standard criteria (Gold standard), at least two of the following:
- Clinical: inflammatory, perforating (fistulising) disease, obstructive symptoms secondary to small bowel stenosis or stricture.
- Endoscopic: deep linear or serpingenous ulcerations, discrete ulcers in normal appearing mucosa, cobble-stoning or discontinuous or asymmetrical inflammation.
- Radiographic: segmental disease (skip lesions), small bowel or colonic strictures, stenosis or fistula.
- Histological: sub-mucosal or transmural inflammation, granulomas, focal cryptitis and chronic inflammatory infiltration, skip lesions including rectal sparing (no topical rectal therapy).
Exclusion
- a) Age below 18 years b) HIV positive c) Malignancy
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT01503099
Start Date
October 1 2009
End Date
December 1 2012
Last Update
January 2 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Population Health & Research Institiute, Medical College
Trivandrum, Kerala, India, 695011
2
Lovisenberg Diakonal Hospital
Oslo, Oslo County, Norway, 0440