Syndecan 1 as Biomarker for Inflammation

February 10, 2019 updated by: Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim

Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • University Medical Center Göttingen
        • Contact:
        • Principal Investigator:
          • Volker Ellenrieder, Prof.
      • Northeim, Lower Saxony, Germany, 37154
        • Helios Albert-Schweitzer-Klinik Northeim
        • Contact:
        • Principal Investigator:
          • Martin Floer, Dr.med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with inflammatoy bowel disease, infectious colitis and healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Soluble serum Syndecan-1 in ng/ml
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Underlying disease
Time Frame: 6 months
6 months
Patient age
Time Frame: 6 Months
6 Months
Disease activity in Inflammatory bowel disease
Time Frame: 6 Months
6 Months
Calprotectin in stool
Time Frame: 6 Months
6 Months
Leucocyte blood count
Time Frame: 6 Months
6 Months
CRP in serum
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helios Albert-Schweitzer-Klinik Northeim

Investigators

  • Principal Investigator: Tobias Meister, PD Dr.med., Helios Albert-Schweitzer-Klinik Northeim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Syndecan-NOM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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