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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05768971

Enrollment

Registered

2023-03-15

Start date

2012-12-06

Completion date

2014-11-14

Last updated

2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Food Allergy

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.

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.

Interventions

OTHERMild diet

OTHERProvocative diet

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026