Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

August 4, 2026 updated by: Akira Horiuchi, Showa Inan General Hospital

Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis

We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy with histology were performed within 7 days.The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity index (CDAI), respectively. The Mayo endoscopy score was evaluated. UC patients whose Mayo endoscopy score was 2 or 3 were divided into the active UC group.

CD patients whose CDAI >150 were divided into the active CD group.

Study Type

Observational

Enrollment (Actual)

673

Contacts and Locations

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

Study Locations

  • Japan
    • Nagano
      • Komagane, Nagano, Japan, 399-4117
        • Showa Inan General Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

In total, a consecutive cohort of 300 patients with possible UC or CD will be enrolled in this study at our hospital.

Description

Inclusion Criteria:

  • Patients whom possible UC or Crohn disease was suspected

Exclusion Criteria:

  • other autoimmune diseases
  • acute or chronic renal failure
  • chronic heart diseases
  • liver cirrhosis
  • cancer
  • acute or chronic systemic infections
  • ischemic colitis

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum LRG measurement
Time Frame: one year
Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients.
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
LRG accuracy
Time Frame: 3 months
The outcome was the difference in areas under the receiver-operating-characteristic curve (AUC) between LRG and CRP for discriminating organic from non-organic gastrointestinal disease, based on continuous marker values.
3 months
Sensitivity & specificity
Time Frame: 3 months
Other outcomes were the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of CRP alone, LRG alone, and the combination of both markers (either test positive), using the fixed cutoffs of CRP ≥ 0.3 mg/dL and LRG ≥ 16 µg/mL, and the proportion of patients with organic disease among CRP-negative/LRG-positive patients.
3 months

Collaborators and Investigators

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

Sponsor

Showa Inan General Hospital

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 (Actual)

October 1, 2020

Primary Completion (Actual)

July 31, 2026

Study Completion (Actual)

July 31, 2026

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LRG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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