1H-19F Gastrointestinal MRI in Health and IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

Small Intestinal Transit and Motor Function in Health and IBS Patients Studied by Combined 1H and 19F Magnetic Resonance Imaging

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01347918
• Other study ID #: GI-MRI
• Secondary ID: 2011-MD-0005
• Status: Suspended
• Phase: N/A
• First received: May 3, 2011
• Last updated: April 8, 2015
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Device:
• 19F capsule
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.

Dietary Supplement:
• sterculia
7g of sterculia will be ingested over one week together with the normal breakfast.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Gastroenterology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small intestinal transit time in minutes		Regularly over 4 hours	No
Secondary	Small intestinal length and intestinal course		at 4 hours	No
Secondary	Small intestinal motor activity index		At 4 hours	No
Secondary	Small intestinal transport velocity		Regularly over 4 hours	No
Secondary	Local intestinal residence times		Regularly over 4 hours.	No
Secondary	Volume and distribution of intestinal gas		Regularly over 4 hours.	No