Detection of Mycobacterium avium ssp paratuberculosis (MAP) forms in patients with Crohn’s disease and controls”- a prospective clinical study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619000940178

Acronym

MAP

Enrollment

Registered

2019-07-05

Start date

2019-07-16

Completion date

2021-11-01

Last updated

2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a single-centre, single-blind, prospective clinical trial evaluating the effect of a new diagnostic test for discrimination of CD and controls. We hypothesised that Mycobacterium avium subspecies paratuberculosis (MAP) is the leading infectious cause for CD. Therefore, developing a simple diagnostic test for MAP detection is worthy of investigation for diagnosis of CD and determining success of anti-mycobacterial therapy in patients with CD. The results of the study will provide evidence for the association between MAP and CD as well as establishing an affordable, less invasive, accurate and efficient diagnostic test for CD and/or monitoring.’

Interventions

Detection of Mycobacterium avium ssp paratuberculosis (MAP) forms in patients with Crohn’s disease and controls. At the screening visit consent will be obtained and a blood sample will be taken to test MAP from the participants. This study will continue for 2 years. If the study subject is a participant with Crohn’s disease the length of his/her participation will be 52 weeks. If the study subject is a participant in the control group, the length of participation will be less than one week.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Outcome results