Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease in Populations of High vs. Low Tuberculosis Endemicity|
- Calprotectin levels in patients with active intestinal tuberculosis [ Time Frame: 18 months ] [ Designated as safety issue: No ]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.
- Levels of calprotectin in patients with intestinal tuberculosis after antituberculous therapy. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Stool samples frozen at -20'C. Blood serum samples frozen at -20'C. Saliva samples stored at room temperature. Paraffin embedded intestinal biopsies.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Patients with active intestinal tuberculosis (ITB)
Healthy subjects serving as controls
Patients with active Crohn's Disease (CD) in India
Patients with active pulmonary tuberculosis (PTB)
Patients with active Crohn's Disease (CD) in Norway
Healthy subjects serving as controls in Norway
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503099
|Contact: Geir larsson, M.D||+47 firstname.lastname@example.org|
|Population Health & Research Institiute, Medical College||Recruiting|
|Trivandrum, Kerala, India, 695011|
|Contact: KT Shenoy, M.D. Ph.D +91 9447044364 email@example.com|
|Principal Investigator: KT Shenoy, M.D Ph.D|
|Sub-Investigator: Geir Larsson, M.D|
|Lovisenberg Diakonal Hospital||Active, not recruiting|
|Oslo, Norway, 0440|
|Study Chair:||Bjorn Moum, M.D Ph.D||Oslo University Hospital, Aker|
|Study Chair:||Gunnar Bjune, M.D Ph.D||University of Oslo, Dept. of International Health|