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

NCT05768971 | Completed

• 1 other identifier: DCEUS_CD_NMA
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease; Food Allergy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (3)

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

Interventions

Mild diet OTHER

Healthy controls; Patients with Food allergy

Provocative diet OTHER

Healthy controls; Patients with Food allergy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Age under 18
• Intolerance of the ultrasound contrast agent SonoVue
• Refusal of participation in the study
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

MeSH Terms

Conditions

Crohn Disease; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dane Wildner, M.D.

  Department of Medicine 1, Divison of ultrasound medicine, University Hospital Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Deputy Head of Ultrasound Department, Department of Internal Medicine 1, Universitätsklinikum Erlangen

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 15, 2023
• Study Start: December 6, 2012
• Primary Completion: November 14, 2014
• Study Completion: November 14, 2014
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share