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

F

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status

Completed

Conditions

Food Allergy
Crohn Disease

Treatments

Other: Provocative diet
Other: Mild diet

Study type

Observational

Funder types

Other

Identifiers

NCT05768971
DCEUS_CD_NMA

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

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

Trial design

48 participants in 3 patient groups

Active Crohn´s disease
Description:
Ultrasound in patients with proven active Crohn´s disease scheduled for therapy with anti tumor necrosis factor alpha antibodies
Patients with Food allergy
Description:
Patients with proven food allergy
Treatment:
Other: Provocative diet
Other: Mild diet
Healthy controls
Description:
Healthy, food-tolerant volunteers without any abdominal complaint
Treatment:
Other: Provocative diet
Other: Mild diet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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