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NCT01861288
Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With Inflammatory Bowel Disease
trial in Inflammatory Bowel Disease in 157 participants. Completed in 28 February 2018.
5 September 2016
Quick facts
| Lead sponsor | Herlev Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 157 |
| Start date | 1 November 2013 |
| Primary completion | 5 September 2016 |
| Estimated completion | 28 February 2018 |
| Sites | 1 location across Denmark |
Conditions studied
- Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
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:
- PubMed search for NCT01861288
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Inflammatory Bowel Disease
Currently open trials in the same condition.
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- NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
- NCT07252427 — Gut Microbiota in IBD With Comorbid Depressive Disorder · recruiting
- NCT06781827 — Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease · NA · recruiting
Other Herlev Hospital trials
Trials by the same sponsor.
- NCT07367412 — Zinc Supplementation and Infections in Older Medical Patients · NA · not yet recruiting
- NCT07171216 — The Effect of REgulation of PArathyroId hoRmone in Patients With Chronic Kidney Disease to Investigate the Change in Bon · NA · recruiting
- NCT07272187 — Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions · recruiting
- NCT07117955 — Platelet-Rich Plasma for Peyronie's Disease · NA · recruiting
- NCT07144046 — Tape Application Protocol for Enhanced Scars · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01861288 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Herlev Hospital
- Last refreshed: 27 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01861288.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing