Contrast-enhanced Ultrasound in Patients With Crohn´s Disease and Food Allergy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Crohn´s disease Ultrasound in patients with proven active Crohn´s disease scheduled for therapy with anti tumor necrosis factor alpha antibodies |
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Patients with Food allergy Patients with proven food allergy |
Other: Mild diet
Other: Provocative diet
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Healthy controls Healthy, food-tolerant volunteers without any abdominal complaint |
Other: Mild diet
Other: Provocative diet
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Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age over 18
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Endoscopically and histologically confirmed active Crohn´s disease or
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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
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Healthy individuals without abdominal complaints
Exclusion Criteria:
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Age under 18
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Intolerance of the ultrasound contrast agent SonoVue
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Refusal of participation in the study
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Pregnancy or breast-feeding
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Friedrich-Alexander-Universität Erlangen-Nürnberg
Investigators
- Principal Investigator: Dane Wildner, M.D., Department of Medicine 1, Divison of ultrasound medicine, University Hospital Erlangen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DCEUS_CD_NMA