Detection of Mycobacterium avium ssp paratuberculosis (MAP) forms in patients with Crohn’s disease and controls”- a prospective clinical study
- Conditions
- Crohn's DiseaseOral and Gastrointestinal - Crohn's diseaseInfection - Other infectious diseases
- Registration Number
- ACTRN12619000940178
- Lead Sponsor
- Centre for Digestive Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 49
•Test group: 40 patients diagnosed with CD or suspected to be diagnosed with CD.
•Controls: 40 patients (no inflammatory bowel disease, no irritable bowel syndrome, no pathology in the terminal ileum) who are referred to the CDD for a routine colonoscopy due to family history of bowel cancer or polyps or similar reason. These participants are ‘normal’ from the point of view of Crohn’s disease which will be excluded on colonoscopy from examination of the terminal ileum. If a patient in the control group” is diagnosed as having Crohn’s disease in the screening period, the participant will still be included in the test group.
•Provide written informed consent to participate as shown by a signature on the consent form.
•Consent not obtained.
•Any contraindications for drug/test – Vaccinated BCG, taking Infliximab or Anti-MAP therapy
•Clinical evidence of any disease which might interfere with the patient’s ability to enter the trial.
•Unable to communicate well with the investigators and to comply with the study requirements.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of MAP in patients with Crohn’s disease compared to controls using blood culture and specific cell-staining techniques..[Crohn's patients will be followed up 12-month.]
- Secondary Outcome Measures
Name Time Method Detection of MAP blood culture using cell-staining method.[Followed up at 3 months and 12 months post blood test.]