1H-19F Gastrointestinal MRI in Health and IBS

NCT01347918 | Suspended

• 2 other identifiers: GI-MRI2011-MD-0005
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Irritable Bowel Syndrome

Keywords

Fluorine MRI, small intestinal transit and motor activity

Outcome Measures

Primary Outcomes (1)

• Small intestinal transit time in minutes

  Regularly over 4 hours

Secondary Outcomes (5)

• Small intestinal length and intestinal course

  at 4 hours

• Small intestinal motor activity index

  At 4 hours

• Small intestinal transport velocity

  Regularly over 4 hours

• Local intestinal residence times

  Regularly over 4 hours.

• Volume and distribution of intestinal gas

  Regularly over 4 hours.

Study Arms (2)

control

Healthy controls

Device: 19F capsule; Dietary Supplement: sterculia

IBS

Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS)

Device: 19F capsule; Dietary Supplement: sterculia

Interventions

19F capsule DEVICE

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.

Also known as: fluorine labeled capsule

IBS; control

sterculia DIETARY_SUPPLEMENT

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

Also known as: Normacol

IBS; control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Gastroenterology

Zurich, Switzerland

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Motor Activity

Interventions

Karaya Gum; Normacol

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Werner Schwizer, Prof. MD

  University Hospital Zurich, Gastroenterology & Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 5, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

CH (1)