Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease

Last updated: December 30, 2011
Sponsor: Lovisenberg Diakonale Hospital
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Ulcerative Colitis

Crohn's Disease

Hiv

Treatment

N/A

Clinical Study ID

NCT01503099
LDS 150
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Above 18 years of age.

  • ITB as per standard criteria a), and one or more of b) to e) must be fulfilled (Goldstandard):

  1. Endoscopic apparent intestinal tuberculosis: transverse ulcers, pseudopolyps,involvement of fewer than four intestinal segments, patulous ileo-coecal valve

  2. Histological evidence of tubercles/granulomas with caseation necrosis inintestinal biopsies

  3. DNA of M.tb detected by PCR of intestinal biopsies

  4. Positive immunohistochemistry in intestinal biopsies.

  5. Histological demonstration of acid fast bacilli in a lesion.

  • Active Crohn's disease as per standard criteria (Gold standard), at least two of thefollowing:

  1. Clinical: inflammatory, perforating (fistulising) disease, obstructive symptomssecondary to small bowel stenosis or stricture.

  2. Endoscopic: deep linear or serpingenous ulcerations, discrete ulcers in normalappearing mucosa, cobble-stoning or discontinuous or asymmetrical inflammation.

  3. Radiographic: segmental disease (skip lesions), small bowel or colonicstrictures, stenosis or fistula.

  4. Histological: sub-mucosal or transmural inflammation, granulomas, focal cryptitisand chronic inflammatory infiltration, skip lesions including rectal sparing (notopical rectal therapy).

Exclusion

Exclusion Criteria: a) Age below 18 years b) HIV positive c) Malignancy

Study Design

Total Participants: 550
Study Start date:
October 01, 2009
Estimated Completion Date:
December 31, 2012

Study 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 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.

Connect with a study center

  • Population Health & Research Institiute, Medical College

    Trivandrum, Kerala 695011
    India

    Active - Recruiting

  • Lovisenberg Diakonal Hospital

    Oslo, 0440
    Norway

    Site Not Available

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