1H-19F Gastrointestinal MRI in Health and IBS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01347918
First received: May 3, 2011
Last updated: April 10, 2012
Last verified: July 2011
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Small intestinal length and intestinal course [ Time Frame: at 4 hours ] [ Designated as safety issue: No ]
  • Small intestinal motor activity index [ Time Frame: At 4 hours ] [ Designated as safety issue: No ]
  • Small intestinal transport velocity [ Time Frame: Regularly over 4 hours ] [ Designated as safety issue: No ]
  • Local intestinal residence times [ Time Frame: Regularly over 4 hours. ] [ Designated as safety issue: No ]
  • Volume and distribution of intestinal gas [ Time Frame: Regularly over 4 hours. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
control
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
IBS
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347918

Contacts
Contact: Andreas Steingoetter, MD andreas.steingoetter@usz.ch

Locations
Switzerland
University Hospital Zurich, Gastroenterology Recruiting
Zurich, Switzerland
Contact: Andreas Steingoetter, Dr.    +41 44 255 56 84    andreas.steingoetter@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Werner Schwizer, Prof. MD University Hospital Zurich, Gastroenterology & Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01347918     History of Changes
Other Study ID Numbers: GI-MRI, 2011-MD-0005
Study First Received: May 3, 2011
Last Updated: April 10, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on August 28, 2014