Specific microRNAs as Potential Biomarker for Inflammatory Bowel Disease

NCT ID: NCT03698500

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

Brief Summary

The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with Crohn's disease (CD) and ulcerative colitis (UC), and to distinguish both entities, infectious colitis and healthy controls. Furthermore, the accuracy of miRNA-320a to distinguish CD or UC from irritable bowel syndrome (IBS) should be evaluated .

The study is designed as a single center non-randomised prospective trial.

Detailed Description

Inflammatory bowel disease (IBD), which comprises Crohn's disease (CD) and ulcerative colitis (UC), is a chronic-remittent disease of the gastrointestinal tract with leading symptoms such as diarrhea, abdominal pain and rectal bleeding. Absence of mucosal inflammation (so called mucosal healing) is a promising treatment target.as it leads to reduction of colectomy rates, hospitalization and need for surgery. However, overtreatment with severe combined immunosuppressive therapy always bears the risk of severe side-effects such as opportunistic infections. To assess the course of disease, clinical evaluation, noninvasive diagnostic or imaging and invasive endoscopic techniques are currently used. As frequent endoscopical monitoring is not always possible, more specific and noninvasive biomarker are needed to monitor disease activity. The commonly used noninvasive biomarkers C-reactive protein and fecal Calprotectin, which are useful to detect disease activity, are limited due to the lacking specificity for IBD and the weak correlation with the extend of disease. Overall the currently available tools to noninvasively follow the course of disease activity do not possess appropriate specificity, sensitivity and cost effectiveness for in- and outpatient clinical monitoring.

Recently, we could demonstrate the potential of miR(microRNA)-320a to monitor disease activity in experimental colitis mouse models.

The aim of this study is to assess the ability of miR-320a and other specific microRNAs to follow the disease course in patients with inflammatory bowel disease as compared to healthy controls, non IBD-colitis and IBS.

The study is planned as a prospective single center study.

Number of patients: 7 groups of 50 patients

• 1: adult CD patients in remission
• 2: adult CD patient with endoscopical proven disease activity
• 3: adult UC patients in remission
• 4: adult UC patient with endoscopical proven disease activity
• 5: adults with infectious colitis (ie. Ischemic, infectious or toxic colitis)
• 6. Adults with IBS
• 7: healthy adults

All eligible individuals are informed about the nature of the study. All individuals provide written informed consent before entering the trial.

Budget:

All procedures in the present study are performed in ordinary patients, with ordinary staff. Therefore, no extra costs occur for personal.

Conditions

Crohn's Disease; Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with intestinal colitis and control patients

Device: qPCR diagnostic of specific microRNAs in peripheral blood (10 ml)

Group Type: OTHER

Removal of blood

Intervention Type: OTHER

10 ml of blood will be removed from a peripheral vene during routine diagnostical blood draw

Interventions

Removal of blood

10 ml of blood will be removed from a peripheral vene during routine diagnostical blood draw

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with Crohn's disease or ulcerative colitis
• Control patients: healthy patients or patients with colitis of other origin than Crohn's disease or ulcerative colitis as well as patients with IBS

Exclusion Criteria

• Age under 18 years
• Pregnancy
• Inability to understand information for participation
• Refusal of participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Friederike Cordes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster, University of Muenster

Locations

University of Muenster

Münster, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Anna Friederike Cordes, MD, PhD

Role: CONTACT

annafriederike.cordes@ukmuenster.de

0049-(0)251-83-47661

Dominik Bettenworth, MD, PhD

Role: CONTACT

dominik.bettenworth@ukmuenster.de

0049-(0)251-83-47661

Facility Contacts

Anna Friederike Cordes, MD, PhD

Role: primary

annafriederike.cordes@ukmuenster.de

+49-251-83-47661

Other Identifiers

FC201603

Identifier Type: -

Identifier Source: org_study_id