NCT01503099

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 2, 2012

Status Verified

December 1, 2011

Enrollment Period

2.2 years

First QC Date

December 30, 2011

Last Update Submit

December 30, 2011

Conditions

Intestinal TuberculosisPulmonary TuberculosisCrohn's Disease

Keywords

ITBPTBCD

Outcome Measures

Primary Outcomes (1)

  • Calprotectin levels in patients with active intestinal tuberculosis

    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.

    18 months

Secondary Outcomes (1)

  • Levels of calprotectin in patients with intestinal tuberculosis after antituberculous therapy.

    18 months

Study Arms (6)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

You may not qualify if:

  • a) Age below 18 years b) HIV positive c) Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Population Health & Research Institiute, Medical College

Trivandrum, Kerala, 695011, India

RECRUITING

Lovisenberg Diakonal Hospital

Oslo, Oslo County, 0440, Norway

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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

    RESULT

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.

MeSH Terms

Conditions

Tuberculosis, PulmonaryCrohn Disease

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • 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

    STUDY CHAIR

Central Study Contacts

Geir larsson, M.D

CONTACT

+47 92045245geirlarsson@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2011

First Posted

January 2, 2012

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

January 2, 2012

Record last verified: 2011-12

Locations

IN(1)NO(1)