Clinical trial NCT03778918: The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group
Official title: The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Keywords: REG3 alpha
IBD
biomarker
ulcerative colitis
serum calprotectin
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Incheon St.Mary's Hospital
name: St Vincent's Hospital
name: Daejeon St. Mary's hospital
First posted: 2018-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control

Brief summary: The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly. Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls. Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease. The outcome is a find of a blood-based biomarker that best reflects a disease activity.

Detailed description: Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy. The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls.

Eligibility criteria: Inclusion Criteria:

* people who receive colonoscopy
* people who sign the consent
* having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome

Exclusion Criteria:

* those aged over 75 years
* the disabled
* pregnant women
* chronic renal diseases (CLcr \<50ml/min)
* blood coagulopathy (PT INR \> 1.5, aPTT \> 45 seconds, or platelet count \< 50,000/mm)
* people who refuse to sign the consent

Primary outcomes:
measure: measurement of blood-based biomarkers to predict disease activity 1
timeFrame: within 12 weeks of the blood sampling
measure: measurement of blood-based biomarkers to predict disease activity 2
timeFrame: within 12 weeks of the blood sampling
measure: measurement of blood-based biomarkers to predict disease activity 3
timeFrame: within 12 weeks of the blood sampling
Secondary outcomes:
measure: Age (years)
timeFrame: at the time of study enrolled
measure: Gender (M/F)
timeFrame: at the time of study enrolled
measure: disease duration (months)
timeFrame: at the time of study enrolled
measure: disease onset (years)
timeFrame: at the time of study enrolled
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology; Seoul St. Mary's hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Bo-In Lee, MD. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darnaud M, Dos Santos A, Gonzalez P, Augui S, Lacoste C, Desterke C, De Hertogh G, Valentino E, Braun E, Zheng J, Boisgard R, Neut C, Dubuquoy L, Chiappini F, Samuel D, Lepage P, Guerrieri F, Dore J, Brechot C, Moniaux N, Faivre J. Enteric Delivery of Regenerating Family Member 3 alpha Alters the Intestinal Microbiota and Controls Inflammation in Mice With Colitis. Gastroenterology. 2018 Mar;154(4):1009-1023.e14. doi: 10.1053/j.gastro.2017.11.003. Epub 2017 Nov 11.
citation: Greuter T, Lang S, Holler E, Hawkey CJ, Rogler G, Biedermann L; ASTIC trial group. Serum REG3alpha and C-Reactive Protein Levels in Crohn's Disease Patients Undergoing Immunoablation and Autologous Hemopoetic Stem Cell Transplantation in the ASTIC Trial. Digestion. 2015;92(2):83-9. doi: 10.1159/000437300. Epub 2015 Aug 1.
citation: Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GVHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8. doi: 10.1016/j.beha.2012.10.010. Epub 2012 Oct 25.