Syndecan 1 as Biomarker for Inflammation
- Conditions
- Colitis
- Registration Number
- NCT02333526
- Lead Sponsor
- Helios Albert-Schweitzer-Klinik Northeim
- Brief Summary
The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from venous blood of patients with infectious intestinal diseases such as Clostridium difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients with active inflammation and with disease in remission. Secondary objectives were the assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be volunteers. Blood will be taken as part of the routine clinical work-up after the written agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In addition, the subjects are asked to answer a short questionnaire. The study is designed as a prospective, comparative cohort study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- Subject with at least 18 years of age
- able to give informed consent
- healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)
- not able to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Soluble serum Syndecan-1 in ng/ml 6 months
- Secondary Outcome Measures
Name Time Method Leucocyte blood count 6 Months Disease activity in Inflammatory bowel disease 6 Months Calprotectin in stool 6 Months CRP in serum 6 Months Underlying disease 6 months Patient age 6 Months
Trial Locations
- Locations (2)
University Medical Center Göttingen
🇩🇪Göttingen, Lower Saxony, Germany
Helios Albert-Schweitzer-Klinik Northeim
🇩🇪Northeim, Lower Saxony, Germany