Intestinal TuberculosisNCT01503099
Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease
An observational study of Intestinal Tuberculosis and Pulmonary Tuberculosis, run by Lovisenberg Diakonale Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intestinal Tuberculosis, Pulmonary Tuberculosis, Crohn's Disease
- How many people
- 550 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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).
Who cannot join
- Age below 18 years b) HIV positive c) Malignancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
India1 site, 1 recruiting
- Recruiting
Population Health & Research Institiute, Medical College
Trivandrum, Kerala, 695011
KT Shenoy, M.D. Ph.D, +91 9447044364, dr.ktshenoy@gmail.com
KT Shenoy, M.D Ph.D
Norway1 site
- Active, not recruiting
Lovisenberg Diakonal Hospital
Oslo, Oslo, 0440
About this study
Official title: Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease in Populations of High vs. Low Tuberculosis Endemicity
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.
Read the 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.
- Keywords
- ITB, PTB, CD
- Medical subject headings
- Tuberculosis, Pulmonary, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
Levels of calprotectin in patients with intestinal tuberculosis after antituberculous therapy.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startOct 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost, The Unger-Vetlesen Medical Fund, Jersey, C.I, Odd Fellow Medical Fund, Norway
- Investigators
- Bjorn Moum, M.D Ph.D, Study chair, Oslo University HospitalGunnar Bjune, M.D Ph.D, Study chair, University of Oslo, Dept. of International Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503099
- Sponsor's protocol ID
- LDS 150
- Status last verified
- Dec 2011
- First submitted
- 30 Dec 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease in Populations of High vs. Low Tuberculosis Endemicity
- ClinicalTrials.gov ID
- NCT01503099
- Acronym / sponsor ID
- LDS 150
- Keywords
- ITB, PTB, CD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost, The Unger-Vetlesen Medical Fund, Jersey, C.I, Odd Fellow Medical Fund, Norway
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Above 18 years of age.
- ITB as per standard criteria a), and one or more of b) to e) must be fulfilled (Gold standard):
- Active Crohn's disease as per standard criteria (Gold standard), at least two of the following:
Key exclusion criteria (1 listed)
- Age below 18 years b) HIV positive c) Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Levels of calprotectin in patients with intestinal tuberculosis after antituberculous therapy.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
- Results publicationLarsson, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjorn Moum, M.D Ph.D study chair
Oslo University Hospital
Gunnar Bjune, M.D Ph.D study chair
University of Oslo, Dept. of International Health
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Tuberculosis and Pulmonary Tuberculosis, run by Lovisenberg Diakonale Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geir larsson, M.D (+47 92045245, geirlarsson@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calprotectin levels in patients with active intestinal tuberculosis (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01503099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.