Balloon-assisted Enteroscopy for Assessment and Correlation with biomarkers in small bowel Crohn's disease

Study for Determining the LRG Cut-off Value Demonstrating Endoscopic Remission of Small-Bowel Lesions in Crohns Disease - BEACON study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059411

Enrollment

243

Registered

2025-11-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Individuals diagnosed with ileal or ileocolonic type Crohn's disease. Individuals scheduled to undergo balloon assisted enteroscopy for lesion assessment. Individuals who provide informed consent to participate and for whom biomarker measurements can be obtained.

Exclusion criteria

Exclusion criteria: Individuals diagnosed with colonic type Crohn's disease. Individuals with evident active perianal disease or perianal abscess. Individuals with conditions contraindicating balloon assisted enteroscopy. Individuals with malignancy; active infections (including the common cold); chronic inflammatory diseases (e.g., rheumatoid arthritis); or other serious comorbidities (e.g., hepatic or renal failure). Individuals who have taken NSAIDs within the past 1 week. Individuals who have taken stimulant laxatives within the past 1 week. Individuals within 3 months of initiating biologic or JAK inhibitor therapy. Pregnant or lactating individuals. Any other individuals deemed unsuitable by the principal investigators.

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of LRG (cut-off 10.5) for ulcerative small-bowel lesions (segmental modified SES-CD maximum 4)	—

Secondary

Measure	Time frame
Evaluate the diagnostic performance of serum, stool, and urine biomarkers for ulcerative small bowel lesions using ROC analysis and contingency tables. Assess correlations between endoscopic scores and serum/stool/urine biomarkers. Examine the relationship between endoscopic findings and serum/stool/urine biomarkers and patient prognosis using the Kaplan Meier method. Investigate changes in diagnostic performance for ulcerative small-bowel lesions when combining multiple biomarkers. Perform stratified (subgroup) analyses of the above primary and secondary endpoints by patient background characteristics.	—

Measure

Time frame

Evaluate the diagnostic performance of serum, stool, and urine biomarkers for ulcerative small bowel lesions using ROC analysis and contingency tables. Assess correlations between endoscopic scores and serum/stool/urine biomarkers. Examine the relationship between endoscopic findings and serum/stool/urine biomarkers and patient prognosis using the Kaplan Meier method. Investigate changes in diagnostic performance for ulcerative small-bowel lesions when combining multiple biomarkers. Perform stratified (subgroup) analyses of the above primary and secondary endpoints by patient background characteristics.

—

Countries

Japan

Contacts

Public ContactKento Takenaka

Science Tokyo Gastroenterology and Hepatology

ktakenaka.gast@tmd.ac.jp03-5803-5877

Outcome results