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

Friedrich-Alexander-Universität Erlangen-Nürnberg48 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease Food Allergy

Interventions

Mild dietOTHER

Provocative dietOTHER

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bowel wall thickness

Thickness of the bowel wall measured in high-frequency ultrasound from the center of the lumen to the serosa

Time frame: T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)

Peak Enhancement

Maximum point of the DCE-US curve assessed in Contrast-Enhanced Ultrasound

Time frame: T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)

Data from ClinicalTrials.gov

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