NCT04088773

Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 232 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This research study will evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.

Detailed description

This multi-center study will test the accuracy of individual and combined MRI and blood-based diagnostic tools in both children and adults with small bowel CD. We will determine the accuracy of a composite tool (including its multiple individual biomarkers) for defining the relative amounts of intestinal inflammation versus scarring in patients at the time of surgery (B2 disease) and in patients at an early stage of disease prior to complications (B1 disease).

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood biomarkers	biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
DIAGNOSTIC_TEST	stool biomarkers	fecal biomarkers of inflammation, mucosal inflammation
DIAGNOSTIC_TEST	MRI imaging	MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-09-01
• Completion: 2026-06-01
• First posted: 2019-09-13
• Last updated: 2025-06-13

Locations

4 sites across 1 country: United States