Prospective, longitudinal, observational study of novel serum/plasma biomarkers of disease activity in patients with inflammatory bowel disease

• Conditions: K50; K51; K52; Crohn disease [regional enteritis]; Ulcerative colitis; Other noninfective gastroenteritis and colitis

• Registration Number: DRKS00013750
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-22
• Study Completion: 2018-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Outpatient visit for study-independent medical reasons
- Patients with a) Crohn's disease, b) Ulcerative Colitis, c) Microscopic colitis
- Patients before therapy start with an (extended) anti-inflammatory treatment (5-ASA, Budesonid, Prednisolon, Azathioprin, Methotrexat, anti-TNF, Vedolizumab, Ustekinumab, Tofacitinib)

Exclusion Criteria

- Stoma
- Diseases which prevent the patient from understanding the nature and the concept of the clinical trial
- Indications that the patient will presumably not comply with the protocol (e.g. adherence problem)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in biomarkers (laboratory analysis, serum samples) in patients who respond to treatment vs. non-responders and controls

Secondary Outcome Measures

Name	Time	Method
Time to reach the change in biomarkers with respect to therapeutic goals