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Status unknownNCT03778918Updated Mar 3, 2020

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

An observational study in Inflammatory Bowel Diseases and Irritable Bowel Syndrome, sponsored by Bo-In Lee. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by Bo-In Lee · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
19 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Inflammatory Bowel Diseases
  • Irritable Bowel Syndrome

Keywords

  • REG3 alpha
  • IBD
  • biomarker
  • ulcerative colitis
  • serum calprotectin
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In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's planned enrollment of 200 is above the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Bo-In Lee is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Otherinflammatory bowel disease

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

  • OtherIBS or Normal Control

    blood based biomarker compared normal control with IBD

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What researchers measure

Primary outcomes

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

    REG3 alpha (ng/mL)

    Time frame: within 12 weeks of the blood sampling

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

    hs-CRP (mg/dL)

    Time frame: within 12 weeks of the blood sampling

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

    serum calprotectin (ng/mL)

    Time frame: within 12 weeks of the blood sampling

Secondary outcomes

  1. Age (years)

    age at the time of study enrolled

    Time frame: at the time of study enrolled

  2. Gender (M/F)

    male of female

    Time frame: at the time of study enrolled

  3. disease duration (months)

    duration of disease

    Time frame: at the time of study enrolled

  4. disease onset (years)

    age at which the disease begins

    Time frame: at the time of study enrolled

07

Study locations

1 of 1 sites recruiting
  • Division of Gastroenterology; Seoul St. Mary's hospital
    Seoul, 137-701, Korea, Republic of
    • Bo-In Lee, MD, PhD · Contact · gidoc4u@gmail.com · 82-10-8367-1055
    • Bo-In Lee, MD, PhD · Principal investigator
    Recruiting
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References and documents

Publications

  • 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. PubMed 29133078 ↗
  • 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. PubMed 26278889 ↗
  • 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. PubMed 23200544 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03778918
Lead sponsor
Bo-In Lee
Collaborators
Incheon St.Mary's Hospital, St Vincent's Hospital, Daejeon St. Mary's hospital
Responsible party
Bo-In Lee (Professor, MD, PhD., Seoul St. Mary's Hospital) — Sponsor-investigator
First posted
Dec 19, 2018
Start date
Aug 1, 2016
Primary completion
Jun 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Mar 3, 2020

Study contacts

Bo-In Lee, MD. Ph.D.
Contact
gidoc4u@gmail.com
82-10-8367-1055
Seungjun Kim, MD.
Contact
gmt475@gmail.com
82-10-8786-2799
Bo-In Lee, MD. Ph.D.
principal investigator · Seoul St. Mary's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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