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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conventional Ultrasound and Quantitative Dynamic Contrast-Enhanced Ultrasound (DCE-US) of the Bowel Wall in Patients With Food Allergy in Comparison to Crohn´s Disease and Healthy Controls

Conditions
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Crohn Disease, Food Allergy

Intervention / Treatment
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* Other: Mild diet
* Other: Provocative diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Crohn´s disease<br>Ultrasound in patients with proven active Crohn´s disease scheduled for therapy with anti tumor necrosis factor alpha antibodies | |
| Patients with Food allergy<br>Patients with proven food allergy | Other: Mild diet<br> <br> Other: Provocative diet<br> <br> |
| Healthy controls<br>Healthy, food-tolerant volunteers without any abdominal complaint | Other: Mild diet<br> <br> Other: Provocative diet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel wall thickness | Thickness of the bowel wall measured in high-frequency ultrasound from the center of the lumen to the serosa | 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 | T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0) |