Crohn DiseaseNCT05768971
Contrast-enhanced Ultrasound in Patients With Crohn´s Disease and Food Allergy
An observational study of Crohn Disease and Food Allergy, run by Friedrich-Alexander-Universität Erlangen-Nürnberg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Food Allergy
- What is being tested?
- Mild diet and Provocative diet
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2012to 14 Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Tertiary-care university hospital, patients diagnosed and treated in the outpatient department for inflammatory and allergic bowel diseases
Who may be able to join
- 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
Who cannot join
- Age under 18
- Intolerance of the ultrasound contrast agent SonoVue
- Refusal of participation in the study
- Pregnancy or breast-feeding
About this study
Official 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
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.
Read the 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.
- Conditions
- Crohn Disease, Food Allergy
- Being tested
- Mild diet, Provocative diet
- Medical subject headings
- Crohn Disease, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild dietOther
Provocative dietOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Mild diet; Other: Provocative diet | |
| Healthy controls | Healthy, food-tolerant volunteers without any abdominal complaint Receives: Other: Mild diet; Other: Provocative diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel wall thickness
Thickness of the bowel wall measured in high-frequency ultrasound from the center of the lumen to the serosa
Measured: 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
Measured: T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start6 Dec 2012
- Primary completion14 Nov 2014
- Study completion14 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dane Wildner, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Dane Wildner, M.D., Principal investigator, Department of Medicine 1, Divison of ultrasound medicine, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768971
- Sponsor's protocol ID
- DCEUS_CD_NMA
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05768971
- Acronym / sponsor ID
- DCEUS_CD_NMA
- Conditions
- Crohn Disease, Food Allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 14 Nov 2014 (actual)
- Study completion
- 14 Nov 2014 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Mild diet, Other: Provocative dietPatients with proven food allergy |
| Healthy controls | – | Other: Mild diet, Other: Provocative dietHealthy, food-tolerant volunteers without any abdominal complaint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary-care university hospital, patients diagnosed and treated in the outpatient department for inflammatory and allergic bowel diseases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Age under 18
- Intolerance of the ultrasound contrast agent SonoVue
- Refusal of participation in the study
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mild diet | Other | Healthy controls, Patients with Food allergy |
| Provocative diet | Other | Healthy controls, Patients with Food allergy |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dane Wildner, M.D. principal investigator
Department of Medicine 1, Divison of ultrasound medicine, University Hospital Erlangen
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Food Allergy, run by Friedrich-Alexander-Universität Erlangen-Nürnberg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel wall thickness (time frame: T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.