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Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With Inflammatory Bowel Disease

NCT01861288 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2019-02-27

No results posted yet for this study

Summary

We hypothesize that the number of needed endoscopic procedure performed at IBD patients (adult and children), can be reduced by using an individualized algorithm of symptoms, blood and faecal biomarkers.

The aim of the study is to reduce the numbers of endoscopies, as the procedure is uncomfortable for the patient, time consuming and expensive. Through indirect tests - blood test, fecal inflammation marker and clinical symptoms - compared to endoscopic findings, we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy.

Furthermore, we will correlate FC, blood tests, clinical symptom score and endoscopic score, with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue, in order to assess the gold standard - endoscopic remission.

Conditions

Sponsors & Collaborators

  • University Hospital of North Norway

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Katrine Carlsen, MD · Departmen of Gastroenterology, Herlev University Hospital

  • Pia Munkholm, Professor · Department of Gastroenterology, Herlev University Hospital

  • Vibeke Wewer, MD, Phd · Hvidovre University Hospital

  • Lene Riis, MD, PhD · Department of Pathology, Herlev University Hospital

  • Christian Jakobsen, MD, PhD · Hvidovre University Hospital

Eligibility

Max Age
67 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2016-09-05
Completion
2018-02-28

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861288 on ClinicalTrials.gov