1H-19F Gastrointestinal MRI in Health and IBS

University of Zurich (UZH)

Status

Suspended

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: sterculia

Device: 19F capsule

Study type

Observational

Funder types

Other

Identifiers

NCT01347918

GI-MRI

2011-MD-0005 (Other Identifier)

Details and patient eligibility

About

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.

Trial with medical device

Enrollment

24 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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:
- Symptoms of recurrent abdominal pain or discomfort and a marked change in bowel habit for at least six months, with symptoms experienced on at least three days of at least three months. Two or more of the following must apply:
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

Age under 18 or above 65
Pathologic underweight or overweight (BMI <18 or >30kg/m2)
Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)
Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse, psychiatric disease
Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal antiinflammatory drugs
Presence of metallic implants, devices or metallic foreign bodies
Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
Female volunteers without adequate contraception for the duration of the study Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
Allergy against silicone
Claustrophobia