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1H-19F Gastrointestinal MRI in Health and IBS

This study has suspended participant recruitment.
(Technical problems)
Information provided by (Responsible Party):
University of Zurich Identifier:
First received: May 3, 2011
Last updated: April 8, 2015
Last verified: April 2015

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

Condition Intervention
Irritable Bowel Syndrome
Device: 19F capsule
Dietary Supplement: sterculia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Small Intestinal Transit and Motor Function in Health and IBS Patients Studied by Combined 1H and 19F Magnetic Resonance Imaging

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Small intestinal transit time in minutes [ Time Frame: Regularly over 4 hours ]

Secondary Outcome Measures:
  • Small intestinal length and intestinal course [ Time Frame: at 4 hours ]
  • Small intestinal motor activity index [ Time Frame: At 4 hours ]
  • Small intestinal transport velocity [ Time Frame: Regularly over 4 hours ]
  • Local intestinal residence times [ Time Frame: Regularly over 4 hours. ]
  • Volume and distribution of intestinal gas [ Time Frame: Regularly over 4 hours. ]

Estimated Enrollment: 24
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy controls
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.
Other Name: fluorine labeled capsule
Dietary Supplement: sterculia
7g of sterculia will be ingested over one week together with the normal breakfast.
Other Name: Normacol
Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS)
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.
Other Name: fluorine labeled capsule
Dietary Supplement: sterculia
7g of sterculia will be ingested over one week together with the normal breakfast.
Other Name: Normacol


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01347918

University Hospital Zurich, Gastroenterology
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Principal Investigator: Werner Schwizer, Prof. MD University Hospital Zurich, Gastroenterology & Hepatology
  More Information

Responsible Party: University of Zurich Identifier: NCT01347918     History of Changes
Other Study ID Numbers: GI-MRI
2011-MD-0005 ( Other Identifier: Swissmedic )
Study First Received: May 3, 2011
Last Updated: April 8, 2015

Keywords provided by University of Zurich:
Fluorine MRI, small intestinal transit and motor activity

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 28, 2017