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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-MD-0005 | Other Identifier | Swissmedic |
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Technical problems
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The aim of this project is to demonstrate and validate the ionizing radiation free and non invasive assessment of small intestinal anatomy, content and function in healthy and disease by a newly developed combined proton (1H) and fluorine (19F) magnetic resonance imaging (MRI) framework. Meal induced and pathology related alterations in small intestinal motor activity, gas distribution and anatomy of healthy volunteers and patients with irritable bowel syndrome (IBS) will be analyzed with this non invasive MRI approach.
The multinuclear imaging framework consists of a 1H and 19F capable clinical 3T MRI system with standard 1H abdominal surface coils, a dual-channel transmit-receive abdominal 19F surface coil, fluorine labelled impermeable and biocompatible capsules for oral administration (19F capsule) and a 19F projection imaging sequence allowing for the non-invasive detection of the gastrointestinal positions of single and multiple ingested capsules in real time. Dedicated post-processing algorithms are applied to extract parameters of intestinal motor activity from the detected intraluminal capsule movements.
The proposed unique imaging modality allows for the concurrent, non invasive and repeated analysis of important physiologic parameters of intestinal function together with detailed anatomical information and thus presents an ideal tool for the evaluation of the analyzed parameters as potential biomarkers in IBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Healthy controls |
| |
| IBS | Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 19F capsule | Device | Two 19F capsules, one filled with hexafluorobenzene (HFB) and the other filled with perfluoro-15-crown-5-ether (PCE) will be administered orally together with 100 ml of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Small intestinal transit time in minutes | Regularly over 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Small intestinal length and intestinal course | at 4 hours | |
| Small intestinal motor activity index | At 4 hours | |
| Small intestinal transport velocity |
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Inclusion criteria:
Healthy volunteers and IBS patients must fill out the validated Birmingham IBS Symptom Questionnaire
Healthy volunteers must be symptom free of any abdominal complaints.
IBS patients are defined based on clinical symptoms as described in the Rome III criteria for irritable bowel syndrome:
Pain is relieved by bowel movement
Onset of pain is related to a change in frequency of stool
Onset of pain is related to a change in the appearance of stool
Written informed consent
Exclusion criteria:
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The healthy controls will be selected from among students and volunteers that have responded to advertisments in local notice boards of the Zurich University Hospital and the University of Zurich, as well as in an email newsletter ("Mediflash") of the Medical Student Organisation.
The IBS patients are selected from the patient population seen in the Klinik and Polyklink für Innere Medizin at the University Hopsital Zurich.
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| Name | Affiliation | Role |
|---|---|---|
| Werner Schwizer, Prof. MD | University Hospital Zurich, Gastroenterology & Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Gastroenterology | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D007618 | Karaya Gum |
| C011045 | Normacol |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| sterculia | Dietary Supplement | 7g of sterculia will be ingested over one week together with the normal breakfast. |
|
|
| Regularly over 4 hours |
| Local intestinal residence times | Regularly over 4 hours. |
| Volume and distribution of intestinal gas | Regularly over 4 hours. |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |