The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group

NCT03778918 | Unknown DMC

• 1 other identifier: XC18TEDI0027
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Keywords

REG3 alpha; IBD; biomarker; ulcerative colitis; serum calprotectin

Outcome Measures

Primary Outcomes (3)

• measurement of blood-based biomarkers to predict disease activity 1

  REG3 alpha (ng/mL)

  within 12 weeks of the blood sampling

• measurement of blood-based biomarkers to predict disease activity 2

  hs-CRP (mg/dL)

  within 12 weeks of the blood sampling

• measurement of blood-based biomarkers to predict disease activity 3

  serum calprotectin (ng/mL)

  within 12 weeks of the blood sampling

Secondary Outcomes (4)

• Age (years)

  at the time of study enrolled

• Gender (M/F)

  at the time of study enrolled

• disease duration (months)

  at the time of study enrolled

• disease onset (years)

  at the time of study enrolled

Study Arms (2)

inflammatory bowel disease

inflammatory bowel disease such as Ulcerative colitis and Crohn's disease

Other: inflammatory bowel disease; Other: IBS or Normal Control

IBS or Normal Control

irritable bowel syndrome patients normal patients

Other: inflammatory bowel disease; Other: IBS or Normal Control

Interventions

inflammatory bowel disease OTHER

blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP

IBS or Normal Control; inflammatory bowel disease

IBS or Normal Control OTHER

blood based biomarker compared normal control with IBD

IBS or Normal Control; inflammatory bowel disease

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bo-In Lee: lead
• Incheon St.Mary's Hospital: collaborator
• St Vincent's Hospital: collaborator
• Daejeon St. Mary's hospital: collaborator

Study Sites (1)

Division of Gastroenterology; Seoul St. Mary's hospital

Seoul, 137-701, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 29133078 BACKGROUND

• 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.

  PMID: 26278889 BACKGROUND

• 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.

  PMID: 23200544 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Biopsy tissue, Stool

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Colitis

Study Officials

• Bo-In Lee, MD. Ph.D.

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo-In Lee, MD. Ph.D.

CONTACT

82-10-8367-1055; gidoc4u@gmail.com

Seungjun Kim, MD.

CONTACT

82-10-8786-2799; gmt475@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD.

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 19, 2018
• Study Start: August 1, 2016
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)