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NCT02333526 Clinical Trial

Syndecan 1 as Biomarker for Inflammation

Colitis Clinical Trial

Official title:
Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02333526
Other study ID # Syndecan-NOM
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2019
Est. completion date July 2020

Study information
Verified date February 2019
Source Helios Albert-Schweitzer-Klinik Northeim
Contact Tobias Meister, PD Dr.med.
Phone +495551971244
Email tobias.meister@helios-kliniken.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 44
Est. completion date July 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject with at least 18 years of age

- able to give informed consent

- healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis)

Exclusion Criteria:

- not able to give informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Medical Center Göttingen Göttingen Lower Saxony
Germany Helios Albert-Schweitzer-Klinik Northeim Northeim Lower Saxony

Sponsors (1)
Lead Sponsor Collaborator
Helios Albert-Schweitzer-Klinik Northeim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Soluble serum Syndecan-1 in ng/ml 6 months
Secondary Underlying disease 6 months
Secondary Patient age 6 Months
Secondary Disease activity in Inflammatory bowel disease 6 Months
Secondary Calprotectin in stool 6 Months
Secondary Leucocyte blood count 6 Months
Secondary CRP in serum 6 Months
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