1H-19F Gastrointestinal MRI in Health and IBS

April 8, 2015 updated by: University of Zurich

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital Zurich, Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • fluorine labeled capsule
Dietary supplement: sterculia
7g of sterculia will be ingested over one week together with the normal breakfast.
Other Names:
  • 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 Names:
  • fluorine labeled capsule
Dietary supplement: sterculia
7g of sterculia will be ingested over one week together with the normal breakfast.
Other Names:
  • Normacol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Small intestinal transit time in minutes
Time Frame: Regularly over 4 hours
Regularly over 4 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI-MRI
  • 2011-MD-0005 (Other Identifier: Swissmedic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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