Contrast-enhanced Ultrasound in Patients With Crohn´s Disease and Food Allergy

Completed

• Conditions: Crohn Disease; Food Allergy
• Interventions: Other: Mild diet; Other: Provocative diet

• Registration Number: NCT05768971
• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg

Brief Summary

The purpose of this study is to investigate differences of the bowel wall thickness visible in conventional ultrasound and bowel perfusion using quantitative Contrast-Enhanced Ultrasound in patients with Crohn´s disease in comparison with healthy controls and patients with food allergy.

Detailed Description

After being informed about the study and potential risks, all participants giving written consent will undergo conventional transabdominal ultrasound and Contrast-Enhanced Ultrasound of the bowel wall with measurement of the bowel wall thickness. In addition a continuous video sequence during Contrast-Enhanced Ultrasound is recorded and perfusion kinetics from the video clips are analyzed using a specific quantification software.

Study Timeline

• Study Start: 2012-12-06
• Primary Completion: 2014-11-14
• Study Completion: 2014-11-14
• Study First Submitted: 2023-02-28
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Age over 18
• Endoscopically and histologically confirmed active Crohn´s disease or
• Previously proven food allergy (double-blind or single-blind food challenge tests with placebo controls previously before the sonographic examination, increased blood and / or intestinal Immunoglobulin E levels, elevated methylhistamine values under provocation and with reproducible reactions during food challenge procedures) or
• Healthy individuals without abdominal complaints

Exclusion Criteria

• Age under 18
• Intolerance of the ultrasound contrast agent SonoVue
• Refusal of participation in the study
• Pregnancy or breast-feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Mild diet	Healthy, food-tolerant volunteers without any abdominal complaint
Patients with Food allergy	Mild diet	Patients with proven food allergy
Patients with Food allergy	Provocative diet	Patients with proven food allergy
Healthy controls	Provocative diet	Healthy, food-tolerant volunteers without any abdominal complaint

Primary Outcome Measures

Name	Time	Method
Bowel wall thickness	T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)	Thickness of the bowel wall measured in high-frequency ultrasound from the center of the lumen to the serosa
Peak Enhancement	T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)	Maximum point of the DCE-US curve assessed in Contrast-Enhanced Ultrasound