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OpenTrials
Completed

NCT Number: NCT05768971

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

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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Key information

Conditions

Crohn Disease Digestive System Diseases Food Allergy Food Hypersensitivity Gastroenteritis Gastrointestinal Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mild diet

Other

Provocative diet

Other

Primary outcomes

  1. Bowel wall thickness

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 15, 2023
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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