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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768971
• Other study ID #: DCEUS_CD_NMA
• Status: Completed
• Start date: December 6, 2012
• Est. completion date: November 14, 2014

Study information

• Verified date: March 2023
• Source: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 14, 2014
• Est. primary completion date: November 14, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Mild diet

• Provocative diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Friedrich-Alexander-Universität Erlangen-Nürnberg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)