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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-06

Study Completion Date

2014-11-14

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.

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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.

Conditions

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Crohn Disease Food Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Patients with Food allergy

Patients with proven food allergy

Mild diet

Intervention Type OTHER

Provocative diet

Intervention Type OTHER

Healthy controls

Healthy, food-tolerant volunteers without any abdominal complaint

Mild diet

Intervention Type OTHER

Provocative diet

Intervention Type OTHER

Interventions

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Mild diet

Intervention Type OTHER

Provocative diet

Intervention Type OTHER

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