Irritable Bowel SyndromeNCT01347918
1H-19F Gastrointestinal MRI in Health and IBS
An observational study of Irritable Bowel Syndrome, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- 19F capsule and sterculia
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2011to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- 19F capsule, sterculia
- Keywords
- Fluorine MRI, small intestinal transit and motor activity
- Medical subject headings
- Irritable Bowel Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19F capsuleDevice
Also called fluorine labeled 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.
sterculiaDietary supplement
Also called Normacol
7g of sterculia will be ingested over one week together with the normal breakfast.
| Study group | Role | What they receive |
|---|---|---|
| control | Healthy controls Receives: Device: 19F capsule; Dietary Supplement: sterculia | |
| IBS | Patients that fulfil the Rome III criteria for irritable bowel syndrome (IBS) Receives: Device: 19F capsule; Dietary Supplement: sterculia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small intestinal transit time in minutes
Measured: Regularly over 4 hours
Secondary outcomes (5)
Small intestinal length and intestinal course
Measured: at 4 hours
Small intestinal motor activity index
Measured: At 4 hours
Small intestinal transport velocity
Measured: Regularly over 4 hours
Local intestinal residence times
Measured: Regularly over 4 hours.
Volume and distribution of intestinal gas
Measured: Regularly over 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Schwizer, Prof. MD, Principal investigator, University Hospital Zurich, Gastroenterology & Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347918
- Sponsor's protocol ID
- GI-MRI
- Other IDs
- 2011-MD-0005
- Status last verified
- Apr 2015
- First submitted
- 3 May 2011
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Intestinal Transit and Motor Function in Health and IBS Patients Studied by Combined 1H and 19F Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01347918
- Acronym / sponsor ID
- GI-MRI
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Fluorine MRI, small intestinal transit and motor activity
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Technical problems
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Device: 19F capsule, Dietary Supplement: sterculiaHealthy controls |
| IBS | – | Device: 19F capsule, Dietary Supplement: sterculiaPatients that fulfil the Rome III criteria for irritable bowel syndrome (IBS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Pain is relieved by bowel movement
- Onset of pain is related to a change in frequency of stool
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 19F capsuleAlso: fluorine labeled capsuleTwo 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. | Device | IBS, control |
| sterculiaAlso: Normacol7g of sterculia will be ingested over one week together with the normal breakfast. | Dietary supplement | IBS, control |
Primary outcome
Small intestinal transit time in minutes
Time frame: Regularly over 4 hours
5 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Schwizer, Prof. MD principal investigator
University Hospital Zurich, Gastroenterology & Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small intestinal transit time in minutes (time frame: Regularly over 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.