Investigating inflammation in Crohn's disease after balloon treatment

Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study

This study is trying to see how balloon treatment for stricturing Crohn's disease affects inflammation in both kids and adults before and after the procedure.

Quick facts

• Study type: Observational
• Enrollment: 24 (estimated)
• Sex: All
• Sponsor: Shaare Zedek Medical Center (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Jerusalem)
• Trial ID: NCT04803916 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of endoscopic balloon dilatation (EBD) on pre-stenotic inflammation in patients with stricturing Crohn's disease. It will include both pediatric and adult patients who are scheduled for EBD and will involve clinical assessments, imaging, serologic testing, and stool microbiome analysis before and after the procedure. The study will track changes in stricture size and inflammation at the stricture site and the pre-stenotic region over a 12-week period. The goal is to better understand the inflammatory load in the bowel following EBD treatment.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with Crohn's disease who have strictures and are planned for endoscopic balloon dilatation.

Not a fit: Patients with active treatment changes or those not meeting the strict eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for Crohn's disease patients with strictures, potentially reducing complications and enhancing quality of life.

How similar studies have performed: While EBD has been shown to be a safe alternative to surgery, the specific focus on pre-stenotic inflammation following EBD is less well-studied, making this approach somewhat novel.

Eligibility criteria

Inclusion criteria:

* Patients diagnosed with CD as per most recent international guidelines.
* Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation \>2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance Enteroclysis (MRE), Computerized Tomography Enteroclysis (CTE) or ultrasound (US))
* Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3.
* Planned EBD as per clinical management.
* Unchanged CD medications - 3 months no change in therapy including immunomodulators (thiopurines or methotrexate), biological therapies, corticosteroid therapy, or nutritional therapy with exclusive enteral nutrition (EEN) or partial enteral nutrition (PEN).
* No planned treatment changes or additions over the 3 months following recruitment. The treating physician can change treatment at any time should the clinical need arise however the patient will be excluded from primary analysis

Exclusion criteria:

* Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included
* Change in therapy (dose or type) in the 3 months prior to planned EBD

Where this trial is running

Jerusalem

• Shaare Zedek — Jerusalem, Israel (RECRUITING)

Study contacts

• Principal investigator: Oren Ledder — Department of Gastroenterology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel
• Study coordinator: Oren Ledder, Dr.

Conditions: Crohn Disease, Crohn, Stricture, Endoscopic Balloon Dilatation