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Significance of Ficolin 2 in the Determination of Serological Activity in Chronic Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT01473927
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : March 12, 2014
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:

Background Determining disease activity in IBD is sometimes difficult and, to be accurate, requires endoscopy. The serum marker CRP has not proven sufficiently valuable as a marker for IBD specific inflammation. As an alternative, so far fecal calprotectin appears to be more reliable and has shown a certain value as predictive marker. Our preliminary data now show, that the serum concentrations of ficolin-2 are significantly higher in CD patients with a HBI >3. Ficolin-2 is a lectin and acute phase protein produced in the liver and, like MBL, can activate the lectin pathway of complement. Unlike MBL, deficiency for ficolin-2 was not detected in our patient cohort, nor could we find functional deficiencies for ficolin-2 (paper submitted).

Study Aims The study is aimed to substantiate the data from our pilot study which shows that ficolin-2 is significantly increased in CD patients during inflammation. Therefore, the study will measure ficolin-2 concentrations in a sufficiently large patient group to obtain enough statistical power and to compare these results with the endoscopic disease score (SES-CD) and CRP and calprotectin values. Statistical analysis of the data will show us if ficolin-2 is a reliable and easy to obtain new marker for active inflammation in CD.

Study Design Based on a power analysis 112 CD patients and 112 UC patients need to be analyzed. They will be recruited from Bern, Basel and Lausanne. Only patients with routine endoscopy will be included in the study and will be scored by SES-CD. Blood samples will be collected at the day of endoscopy. Stool sample will be collected within the same week of endoscopy. Calprotectin and CRP concentrations will be determined by routine diagnostics, ficolin-2 concentrations will be determined by ELISA in our laboratory. Finally, all data will be statistically analyzed.


Condition or disease Intervention/treatment
Crohn Disease Other: Endoscopy

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Significance of Ficolin 2 in the Determination of Serological Activity in Chronic Inflammatory Bowel Disease
Study Start Date : October 2011
Primary Completion Date : February 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
1
Crohn's Disease patients
Other: Endoscopy
Only patients undergoing endoscopy for clinical reasons will be included in the study, i.e. no endoscopies will be performed solely for study reasons. For the purposes of our study, endoscopy serves to determine the degree of inflammation and no additional biopsies are taken. Blood for CRP and ficolin-2 analysis will be taken through the Venflon® installed for endoscopy.
2
Ulcerative colitis patients
Other: Endoscopy
Only patients undergoing endoscopy for clinical reasons will be included in the study, i.e. no endoscopies will be performed solely for study reasons. For the purposes of our study, endoscopy serves to determine the degree of inflammation and no additional biopsies are taken. Blood for CRP and ficolin-2 analysis will be taken through the Venflon® installed for endoscopy.


Outcome Measures

Primary Outcome Measures :
  1. Ficolin-2 concentration in serum [ Time Frame: During endoscopy ]

Secondary Outcome Measures :
  1. CRP concentration in serum [ Time Frame: During endoscopy ]
  2. Calprotectin in stool sample [ Time Frame: One week before endoscopy up to one week after endoscopy ]

Biospecimen Retention:   Samples With DNA
Serum Stool

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All CD and UC patients undergoing endoscopy for clinical reasons at one of the involved clinical centers.
Criteria

Inclusion Criteria:

  • known IBD
  • endoscopy for clinical reasons
  • enrolled in the Swiss IBD cohort study

Exclusion Criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473927


Locations
Switzerland
Gastroenterology and Hepatology, Basel University Hospital
Basel, Basel Stadt, Switzerland, 4031
Service de gastro-entérologie et hépatologie, CHUV Lausanne
Lausanne, Vaud, Switzerland, 1011
DCR, Gastroenterology, Bern, University of Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
Swiss IBD Cohort Study
MSD Merck Sharp & Dohme AG
Investigators
Study Director: Frank Seibold, Prof. Dr. med. Spital Tiefenau / Inselspital Bern
More Information

Publications:
Responsible Party: Seibold Prof. Dr. med., Spital Tiefenau Bern / Inselspital Bern
ClinicalTrials.gov Identifier: NCT01473927     History of Changes
Other Study ID Numbers: 110/06
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by University of Bern:
Inflammatory bowel diseases
Crohn disease
Ficolin-2
C-Reactive Protein
Calprotectin
Inflammatory markers
SES-CD

Additional relevant MeSH terms:
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases