Blood LRG levels as a marker of ulcerative colitis and Crohn's disease activity
Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis
This will test whether blood levels of leucine-rich alpha-2 glycoprotein (LRG) match disease activity in people with suspected ulcerative colitis or Crohn's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Showa Inan General Hospital Academic / other |
| Locations | 1 site (Komagane, Nagano) |
| Trial ID | NCT04535882 on ClinicalTrials.gov |
What this trial studies
This observational study measured serum LRG levels and compared them with clinical and endoscopic measures of disease activity in patients with suspected UC or CD. Serum sampling and colonoscopy with histology were performed within seven days and clinical records were reviewed to obtain Mayo scores for UC, the Crohn's Disease Activity Index (CDAI) for CD, and the Mayo endoscopy score. Patients with a Mayo endoscopy score of 2–3 were classified as active UC and those with CDAI >150 as active CD. The analysis aimed to determine whether serum LRG correlates with endoscopic inflammation and could serve as a predictive blood marker.
Who should consider this trial
Good fit: Adults with suspected ulcerative colitis or Crohn's disease who can undergo blood sampling and colonoscopy within seven days are the intended participants.
Not a fit: Patients with excluded comorbid conditions—such as other autoimmune diseases, advanced organ failure, cancer, or active infections—are unlikely to benefit from this study's results.
Why it matters
Potential benefit: If successful, a blood LRG test could provide a less invasive way to monitor intestinal inflammation and help guide treatment decisions.
How similar studies have performed: Previous studies have suggested LRG may correlate with IBD activity but evidence remains limited, so this study adds additional observational data rather than proving clinical utility.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Komagane, Nagano
- Showa Inan General Hospital — Komagane, Nagano, Japan (Recruiting)
Study contacts
- Study coordinator: Akira Horiuchi, MD
- Email: horiuchi.akira@sihp.jp
- Phone: 81265822121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.