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

Friedrich-Alexander-Universität Erlangen-Nürnberg (Other)
Overall Status
Completed ID

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
  • Other: Mild diet
  • Other: Provocative diet

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

Study Type:
Actual Enrollment :
48 participants
Observational Model:
Time Perspective:
Official Title:
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
Actual Study Start Date :
Dec 6, 2012
Actual Primary Completion Date :
Nov 14, 2014
Actual Study Completion Date :
Nov 14, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Crohn´s disease

Ultrasound in patients with proven active Crohn´s disease scheduled for therapy with anti tumor necrosis factor alpha antibodies

Patients with Food allergy

Patients with proven food allergy

Other: Mild diet

Other: Provocative diet

Healthy controls

Healthy, food-tolerant volunteers without any abdominal complaint

Other: Mild diet

Other: Provocative diet

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Friedrich-Alexander-Universität Erlangen-Nürnberg


  • 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


None provided.
Responsible Party:
Dane Wildner, Principal Investigator - Deputy Head of Ultrasound Department, Department of Internal Medicine 1, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg Identifier:
Other Study ID Numbers:
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023