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Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease

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ClinicalTrials.gov Identifier: NCT01503099
Recruitment Status : Unknown
Verified December 2011 by Lovisenberg Diakonale Hospital.
Recruitment status was:  Recruiting
First Posted : January 2, 2012
Last Update Posted : January 2, 2012
Information provided by:

Study Description
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.

Condition or disease
Intestinal Tuberculosis Pulmonary Tuberculosis Crohn's Disease

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.

Study Design

Study Type : Observational
Estimated Enrollment : 550 participants
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
Study Start Date : October 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Active ITB
Patients with active intestinal tuberculosis (ITB)
Controls India
Healthy subjects serving as controls
CD India
Patients with active Crohn's Disease (CD) in India
Active PTB
Patients with active pulmonary tuberculosis (PTB)
CD Norway
Patients with active Crohn's Disease (CD) in Norway
Controls Norway
Healthy subjects serving as controls in Norway

Outcome Measures

Primary Outcome Measures :
  1. Calprotectin levels in patients with active intestinal tuberculosis [ Time Frame: 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 Outcome Measures :
  1. Levels of calprotectin in patients with intestinal tuberculosis after antituberculous therapy. [ Time Frame: 18 months ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Consecutive patients from four secondary or tertiary care referral centres in the two southernmost states in India (Kerala and Tamil Nadu).

Consecutive patients from nine secondary or tertiary care referral centres in South-East Norway.


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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503099

Contact: Geir larsson, M.D +47 92045245 geirlarsson@yahoo.com

Population Health & Research Institiute, Medical College Recruiting
Trivandrum, Kerala, India, 695011
Contact: KT Shenoy, M.D. Ph.D    +91 9447044364    dr.ktshenoy@gmail.com   
Principal Investigator: KT Shenoy, M.D Ph.D         
Sub-Investigator: Geir Larsson, M.D         
Lovisenberg Diakonal Hospital Active, not recruiting
Oslo, Norway, 0440
Sponsors and Collaborators
Lovisenberg Diakonale Hospital
Helse Sor-Ost
The Unger-Vetlesen Medical Fund, Jersey, C.I
Odd Fellow Medical Fund, Norway
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
More Information

Larsson, G; Shenoy, KT; Roseth, A; Bjune, G; Moum, B. Diagnosis and differentiation of intestinal tuberculosis and Crohn's disease by use of faecal and serum calprotectin. INFLAMMATORY BOWEL DISEASES 17: S35-S35 Suppl. 1 JAN 2011

Responsible Party: Bjorn Moum, Oslo University Hospital, Aker
ClinicalTrials.gov Identifier: NCT01503099     History of Changes
Other Study ID Numbers: LDS 150
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011

Keywords provided by Lovisenberg Diakonale Hospital:

Additional relevant MeSH terms:
Crohn Disease
Tuberculosis, Pulmonary
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections