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NCT01861288

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

Completed Last updated 27 February 2019
What this trial tests

trial in Inflammatory Bowel Disease in 157 participants. Completed in 28 February 2018.

Timeline
1 November 2013
Primary endpoint
5 September 2016
28 February 2018

Quick facts

Lead sponsorHerlev Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment157
Start date1 November 2013
Primary completion5 September 2016
Estimated completion28 February 2018
Sites1 location across Denmark

Conditions studied

Sponsor

Herlev Hospital

Who can join

Under 67, any sex, with Inflammatory Bowel Disease or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Inflammatory Bowel Disease

Currently open trials in the same condition.

Other Herlev Hospital trials

Trials by the same sponsor.

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Data sources for this page

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