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

NCT01861288 | Completed

• 1 other identifier: DER-SBIO
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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

Inflammatory Bowel Disease; Crohn Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Disease; Fecal Calprotectin; Clinical IBD score (SCCAI, PUCAI, aPCDAI); Endoscopic deep remission; Histopathologic deep remission; Immunological deep remission; Treatment algorithm

Outcome Measures

Primary Outcomes (1)

• Fecal Calprotectin (FC)and clinical score

  FC is an inflammation marker from intestinal mucosa. Clinical score by Simple Clinical Colitis Activity Index, SCCAI. SCCAI is a specific Ulcerative Colitis index.

  Two FC test will be analysed up to 1 week before the endoscopy. SCCAI will be collected up to 1 week before endoscopy.

Secondary Outcomes (1)

• Histopathological and Immunological inflammation score

  up to 8 weeks after endoscopy

Other Outcomes (1)

• Endoscopic-, Histopathological- and Immunological- intestinal inflammation in children with IBD

  Up to 2 years after endoscopy

Study Arms (1)

Adults and children with and without IBD

The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy). Inclusion of adult patients, age 15-67 years: 50 patients with UC in remission, 50 patients with active UC, 50 patients without IBD Inclusion of pediatric patients, \<15 years: We expect to include: 10 UC / CD patients in remission,10 UC / CD patients in relapse,10 non-IBD patients.

Eligibility Criteria

• Age: Up to 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes adult and pediatric patients with and without IBD who, as part of an ongoing investigation or treatment, have to undergo a sigmoidoscopy (for children: colonoscopy).

You may qualify if:

• Patients scheduled for endoscopy
• Age 0 - 67 years
• Intestinal infections ruled out by stool sample analysis for pathogenic bacteria, parasites and Clostridium difficile
• CMV ruled out
• Fluent in Danish

You may not qualify if:

• American Society of Anesthesiologists (ASA) score III or above
• Patients who are alcohol or drug abusers

Sponsors & Collaborators

• Herlev Hospital: lead
• University Hospital of North Norway: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Katrine Carlsen

Herlev, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Katrine Carlsen, MD

  Departmen of Gastroenterology, Herlev University Hospital

  PRINCIPAL INVESTIGATOR

• Pia Munkholm, Professor

  Department of Gastroenterology, Herlev University Hospital

  STUDY DIRECTOR

• Vibeke Wewer, MD, Phd

  Hvidovre University Hospital

  STUDY CHAIR

• Lene Riis, MD, PhD

  Department of Pathology, Herlev University Hospital

  STUDY CHAIR

• Christian Jakobsen, MD, PhD

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 23, 2013
• Study Start: November 1, 2013
• Primary Completion: September 5, 2016
• Study Completion: February 28, 2018
• Last Updated: February 27, 2019

Record last verified: 2018-02

Locations

DK (1)