Crohn's Disease, Intestinal Tuberculosis, Pulmonary Tuberculosis
Conditions
Keywords
ITB, PTB, CD
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 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.
Interventions
None listed
Sponsors
Helse Sor-Ost
The Unger-Vetlesen Medical Fund, Jersey, C.I
Odd Fellow Medical Fund, Norway
Lovisenberg Diakonale Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Above 18 years of age. * ITB as per standard criteria a), and one or more of b) to e) must be fulfilled (Gold standard): 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 in intestinal 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 the following: 1. Clinical: inflammatory, perforating (fistulising) disease, obstructive symptoms secondary to small bowel stenosis or stricture. 2. Endoscopic: deep linear or serpingenous ulcerations, discrete ulcers in normal appearing mucosa, cobble-stoning or discontinuous or asymmetrical inflammation. 3. Radiographic: segmental disease (skip lesions), small bowel or colonic strictures, stenosis or fistula. 4. Histological: sub-mucosal or transmural inflammation, granulomas, focal cryptitis and chronic inflammatory infiltration, skip lesions including rectal sparing (no topical rectal therapy).
Exclusion criteria
a) Age below 18 years b) HIV positive c) Malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calprotectin levels in patients with active intestinal tuberculosis | 18 months | Establishment of serum and faecal calprotectin levels in patients with active intestinal tuberculosis in comparison with healthy control subjects, patients with Crohn's Disease and patients with active pulmonary tuberculosis. |
Secondary
| Measure | Time frame |
|---|---|
| Levels of calprotectin in patients with intestinal tuberculosis after antituberculous therapy. | 18 months |
Countries
India, Norway
Contacts
Primary ContactGeir larsson, M.D
Outcome results
None listed