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

LRG Levels Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535882
• Other study ID #: LRG
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Showa Inan General Hospital
• Contact: Akira Horiuchi, MD
• Phone: 81265822121
• Email: horiuchi.akira[@]sihp.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: N/A and older

Eligibility

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 infections

• ischemic colitis

• infectious colitis

Related Conditions & MeSH terms

• LRG Levels

Intervention

Diagnostic Test:
• serum leucine-rich alpha-2 glycoprotein (LRG) levels
Patients who were diagnosed with possible UC or Crohn disease according to endoscopic, radiological, histological, and clinical criteria were enrolled. 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 were performed within 7 days.

Locations

Country	Name	City	State
Japan	Showa Inan General Hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum LRG measurement	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