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

March 13, 2023 updated by: Dane Wildner, Friedrich-Alexander-Universität Erlangen-Nürnberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

48

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary-care university hospital, patients diagnosed and treated in the outpatient department for inflammatory and allergic bowel diseases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)
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
T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Investigators

  • Principal Investigator: Dane Wildner, M.D., Department of Medicine 1, Divison of ultrasound medicine, University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2012

Primary Completion (Actual)

November 14, 2014

Study Completion (Actual)

November 14, 2014

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCEUS_CD_NMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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