Irritable Bowel SyndromeNCT01534507
Small and Large Bowel Transit Tests Using MRI (Study 1)
An observational study of Irritable Bowel Syndrome, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort along with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two (referred to as IBS subtypes). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Aug 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be selected via poster advertisement Participants with Irritable Bowel Syndrome will be selected from the gastroenterology clinics /poster advertisement
Who may be able to join
- 26 healthy volunteer
- Age 18-75 years old
- Non-smoker
- Able to give informed consent
- Meet the Rome III criteria and the IBS subtypes
- Age 18-75 years old
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- Able to give informed consent
- Subjects will undergo a limited screening medical. They will also complete a MRI - safety questionnaire and be given an information sheet
- Able to give informed consent
- Subjects will undergo screening medical questionnaire. They will also complete a MRI safety questionnaire and be given an information sheet
Who cannot join
- Lactose intolerant
- Any history of gastrointestinal surgery on the small bowel (excluding appendicectomy)
- Pregnancy
- contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury alcohol dependence
- serious concomitant illness as judged by the investigators
- use of drugs known to alter GI motility including opiates, anti-depressants, selective serotonin reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test
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- inability to lie flat or exceed scanner limits of weight >120kg or abdominal circumference >99cm ; BMI <18 and >30 kg/m2
- Poor command of English language
- Participation of any medical trials for the past 3 months
- Study 2:
- 120 participants consisting of: 30 patients with diarrhoea predominant IBS according to Rome III criteria 30 patients with constipation predominant IBS according to Rome III criteria 30 patients with mixed type IBS according to Rome III criteria 30 healthy volunteers age and sex matched controls
- Any history of gastrointestinal surgery on the small bowel (excluding appendicectomy)
- Pregnancy
- contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- alcohol dependence
- serious concomitant illness as judged by the investigators
- use of drugs known to alter GI motility including opiates, , monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test
- Selective serotonin reuptake inhibitors or low dose tricyclic antidepressants will be recorded but will not be an exclusion
- No recent antibiotic treatment past 2 weeks
- inability to lie flat or exceed scanner limits of weight >120kg or abdominal circumference >99cm; BMI <18 and >30 kg/m2
- Poor command of English language
- Participation of any medical trials for the past 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Notts, NG7 2UH
About this study
Official title: Optimising Measurement of Small and Large Bowel Transit During MRI Scanning and Characterising IBS Subtypes and Their Response to Stress Using MRI (Study 1)
Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort along with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two (referred to as IBS subtypes). Despite much research efforts to further understand the pathophysiology of IBS; as yet no specific biomarkers/definitive measurements have been identified that can be use to aid the diagnosis and reduce the need for unnecessary, unpleasant and expensive tests.
Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small bowel. In this study, the investigators hypothesise that since anxiety is a common feature of IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the difference in stool frequency and consistency in IBS subgroups are therefore likely to reflect differences in colonic function. The investigator wish to test this by measuring both small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate the results of the MRI with two methods currently used in clinical practice -The previously validated lactose-C13 Ureide breath test (for small bowel transit) and the standard radio-opaque pellet method to assess the whole gut transit (WGT) time.
Read the detailed description
The investigator has 2 main parts in this study i.e. Study 1 and Study 2.
As part of study 1, the investigator would like to recruit up to 5 healthy volunteers as a pilot study to optimise measurement and analysis of the Lactose-C13 Ureide breath test along with MRI scannings at regular intervals.
Following from this, the investigator would like assess the feasibility and reproducibility of using MRI imaging to assess gastrointestinal transit. The investigator would like to recruit 21 healthy volunteers to measure orocaecal transit time (OCTT) and whole gut transit(WGT)using the conventional method of Lactose-C13 Ureide breath test for OCTT and the Metcalf method using standard radio-opaque pellet method for WGT and compare them will MRI imaging. Once this has been analysed and the best method for each OCTT and WGT have been decided, these methods would be applied in Study 2.
In study 2, the investigator would like to recruit 30 healthy volunteers, 30 patients with diarrhoea predominantly Irritable Bowel Syndrome, 30 patients with constipation predominantly Irritable Bowel Syndrome and 30 patients with Mixed irritable Bowel Syndrome. The best methods from study 1 for OCTT and WGT will be applied here to assess gastrointestinal transit on these subjects. Based on the first study, the best method to assess OCTT is the Lactose-C13 Ureide breath test and for the WGT, the best method is the MRI marker capsules. Participants will need to fill in questionnaires to assess their stress levels and to fill in symptom questionnaires during the study day.
- Conditions
- Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer 1 (Group 1) | For study 1 : Up to 5 healthy volunteers for the initial pilot study and further 21 healthy volunteers for the main study 1 | |
| Group 2 for study 2 | Patients with diarrhoea due to irritable bowel syndrome | |
| Group 3 for study 2 | Patients with constipation due to irritable bowel syndrome | |
| Group 4 for study 2 | Patients with mixed bowel habit due to irritable bowel syndrome | |
| Group 5 for study 2: Healthy volunteer 2 | Healthy participants to act as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1:Correlation between mean orocaecal transit time as assessed by MRI and lactose C13-ureide
MRI:Orocaecal transit time (OCTT) can be measured by the first scan showing arrival of the head of a meal in the ascending colon Lactose C13-Ureide breath test:Orocaecal transit time will be taken as the time at which a significant increase from background in breath 13C was seen.
Measured: 9 hours
Study 1: Correlation between colonic transit as assessed by from the geometric centre of the PTFE capsule at time 24 and 48 hours and Metcalf Radio-opaque marker method
Colonic transit using MRI will be measure by assessing the geometric centre position in colon/small bowel.
Whole gut transit time using the Metcalf method of Radio-opaque Marker method would be estimated by counting the number of pellets remaining in the colon in an abdominal x-ray taken in day 4 * 1.2
Measured: 72 hours
Study 2: Fasting small bowel water content
Fasting small bowel water content (SBWC) in the 3 subgroups of Irritable Bowel Syndrome (IBS) compared to healthy controls
Measured: 1 hour
Secondary outcomes (7)
Study 1:To assess reproducibility of the using MRI for orocaecal transit time and colonic transit time
In study 1, the orocaecal transit time and colonic transit time would be repeated twice with a week break in between to assess reproducibility of the MRI.
Measured: 21 days
Study 2: Orocaecal transit time using lactose C13-ureide
Orocaecal transit time in the 3 subgroups of IBS versus healthy control using the best method from study 1 which is the lactose C13-Ureide breath test
Measured: 9 hours
Study 2: Area under the curve (AUC) post prandial SBWC
Measured: 9 hours
Study 2: Ascending colon water content (ACWC) and colonic water index (CWI)
Measured: 9 hours
Study 2: Colonic volumes both fasting and post prandial (divided into ascending transverse and descending colon)
Measured: 9 hours
Study 2: Whole gut transit time assess by MRI marker capsule from study 1
The best method to assess the whole gut transit time based on study 1 was the use of the MRI marker capsule at time 24hours
Measured: 24 hours
Study 2: Correlation between the Hospital Anxiety & Depression Scale (HADS) and other measures of anxiety and stress score and (a) Oro-caecal transit time and (b)whoe gut transit time
Measured: 9hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, MD FRCP, Study director, University of NottinghamChing Lam, MBchB MRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534507
- Sponsor's protocol ID
- 11038
- Other IDs
- 11/EM/0245 (Study 1)
- Status last verified
- Aug 2014
- First submitted
- 13 Feb 2012
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Metcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. doi: 10.1016/0016-5085(87)90837-7.
PubMed 3023168Chaddock G, Lam C, Hoad CL, Costigan C, Cox EF, Placidi E, Thexton I, Wright J, Blackshaw PE, Perkins AC, Marciani L, Gowland PA, Spiller RC. Novel MRI tests of orocecal transit time and whole gut transit time: studies in normal subjects. Neurogastroenterol Motil. 2014 Feb;26(2):205-14. doi: 10.1111/nmo.12249. Epub 2013 Oct 25.
PubMed 24165044
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Measurement of Small and Large Bowel Transit During MRI Scanning and Characterising IBS Subtypes and Their Response to Stress Using MRI (Study 1)
- ClinicalTrials.gov ID
- NCT01534507
- Acronym / sponsor ID
- 11038
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Feb 2012 (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.
Irritable bowel syndrome, (IBS) is a common functional disorder of the gut that can be quite disabling to patients. The most common symptoms of IBS are abdominal pain or discomfort along with erratic changes in bowel habit of diarrhoea, constipation or a mixture of the two (referred to as IBS subtypes). Despite much research efforts to further understand the pathophysiology of IBS; as yet no specific biomarkers/definitive measurements have been identified that can be use to aid the diagnosis and reduce the need for unnecessary, unpleasant and expensive tests.
Evidence shows that anxiety plays a part in IBS and can speed up transit time in the small bowel. In this study, the investigators hypothesise that since anxiety is a common feature of IBS, then fast small bowel transit is likely to be found in all subtypes of IBS and the difference in stool frequency and consistency in IBS subgroups are therefore likely to reflect differences in colonic function. The investigator wish to test this by measuring both small and large bowel transit times using Magnetic Resonance Imaging (MRI) and validate the results of the MRI with two methods currently used in clinical practice -The previously validated lactose-C13 Ureide breath test (for small bowel transit) and the standard radio-opaque pellet method to assess the whole gut transit (WGT) time.
Detailed description
The investigator has 2 main parts in this study i.e. Study 1 and Study 2.
As part of study 1, the investigator would like to recruit up to 5 healthy volunteers as a pilot study to optimise measurement and analysis of the Lactose-C13 Ureide breath test along with MRI scannings at regular intervals.
Following from this, the investigator would like assess the feasibility and reproducibility of using MRI imaging to assess gastrointestinal transit. The investigator would like to recruit 21 healthy volunteers to measure orocaecal transit time (OCTT) and whole gut transit(WGT)using the conventional method of Lactose-C13 Ureide breath test for OCTT and the Metcalf method using standard radio-opaque pellet method for WGT and compare them will MRI imaging. Once this has been analysed and the best method for each OCTT and WGT have been decided, these methods would be applied in Study 2.
In study 2, the investigator would like to recruit 30 healthy volunteers, 30 patients with diarrhoea predominantly Irritable Bowel Syndrome, 30 patients with constipation predominantly Irritable Bowel Syndrome and 30 patients with Mixed irritable Bowel Syndrome. The best methods from study 1 for OCTT and WGT will be applied here to assess gastrointestinal transit on these subjects. Based on the first study, the best method to assess OCTT is the Lactose-C13 Ureide breath test and for the WGT, the best method is the MRI marker capsules. Participants will need to fill in questionnaires to assess their stress levels and to fill in symptom questionnaires during the study day.
Study design
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer 1 (Group 1) | – | –For study 1 : Up to 5 healthy volunteers for the initial pilot study and further 21 healthy volunteers for the main study 1 |
| Group 2 for study 2 | – | –Patients with diarrhoea due to irritable bowel syndrome |
| Group 3 for study 2 | – | –Patients with constipation due to irritable bowel syndrome |
| Group 4 for study 2 | – | –Patients with mixed bowel habit due to irritable bowel syndrome |
| Group 5 for study 2: Healthy volunteer 2 | – | –Healthy participants to act as control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be selected via poster advertisement Participants with Irritable Bowel Syndrome will be selected from the gastroenterology clinics /poster advertisement
Key inclusion criteria (10 listed)
- 26 healthy volunteer
- Age 18-75 years old
- Non-smoker
- Able to give informed consent
- Meet the Rome III criteria and the IBS subtypes
Key exclusion criteria (22 listed)
- Lactose intolerant
- Any history of gastrointestinal surgery on the small bowel (excluding appendicectomy)
- Pregnancy
- contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury alcohol dependence
- serious concomitant illness as judged by the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study 1:Correlation between mean orocaecal transit time as assessed by MRI and lactose C13-ureide
Time frame: 9 hours
MRI:Orocaecal transit time (OCTT) can be measured by the first scan showing arrival of the head of a meal in the ascending colon Lactose C13-Ureide breath test:Orocaecal transit time will be taken as the time at which a significant increase from background in breath 13C was seen.
Study 1: Correlation between colonic transit as assessed by from the geometric centre of the PTFE capsule at time 24 and 48 hours and Metcalf Radio-opaque marker method
Time frame: 72 hours
Colonic transit using MRI will be measure by assessing the geometric centre position in colon/small bowel. Whole gut transit time using the Metcalf method of Radio-opaque Marker method would be estimated by counting the number of pellets remaining in the colon in an abdominal x-ray taken in day 4 * 1.2
Study 2: Fasting small bowel water content
Time frame: 1 hour
Fasting small bowel water content (SBWC) in the 3 subgroups of Irritable Bowel Syndrome (IBS) compared to healthy controls
7 secondary outcomes
Study 1:To assess reproducibility of the using MRI for orocaecal transit time and colonic transit time
Time frame: 21 days
Study 2: Orocaecal transit time using lactose C13-ureide
Time frame: 9 hours
Study 2: Area under the curve (AUC) post prandial SBWC
Time frame: 9 hours
Study 2: Ascending colon water content (ACWC) and colonic water index (CWI)
Time frame: 9 hours
Study 2: Colonic volumes both fasting and post prandial (divided into ascending transverse and descending colon)
Time frame: 9 hours
Study 2: Whole gut transit time assess by MRI marker capsule from study 1
Time frame: 24 hours
Study 2: Correlation between the Hospital Anxiety & Depression Scale (HADS) and other measures of anxiety and stress score and (a) Oro-caecal transit time and (b)whoe gut transit time
Time frame: 9hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
- Background: PubMed 3023168Metcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. doi: 10.1016/0016-5085(87)90837-7.
- Results publication: PubMed 24165044Chaddock G, Lam C, Hoad CL, Costigan C, Cox EF, Placidi E, Thexton I, Wright J, Blackshaw PE, Perkins AC, Marciani L, Gowland PA, Spiller RC. Novel MRI tests of orocecal transit time and whole gut transit time: studies in normal subjects. Neurogastroenterol Motil. 2014 Feb;26(2):205-14. doi: 10.1111/nmo.12249. Epub 2013 Oct 25.
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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.
Robin Spiller, MD FRCP study director
University of Nottingham
Ching Lam, MBchB MRCP principal investigator
University of Nottingham
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 Nottingham at 1 site in United Kingdom.
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 10 inclusion and 22 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: finished, as of the sponsor's last update on 13 Aug 2014. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study 1:Correlation between mean orocaecal transit time as assessed by MRI and lactose C13-ureide (time frame: 9 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534507, which also lists 2 linked publications.
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 13 Aug 2014.