Investigating inflammation in Crohn's disease after balloon treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: orenl@szmc.org.il
• Phone: +972-2-6666743

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.