ConstipationMIMICNCT02144376
MRI and Microbiota Analysis in Constipation
A study testing Ispaghula and Maltodextrin in people with Constipation, run by University of Nottingham at 2 sites in United Kingdom.
Trial summary
The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Ispaghula and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2014to Jun 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets Rome III Criteria for diagnosis of Functional Constipation5 on questionnaire (NB. Both those who do and do not meet IBS criteria will be eligible)
- At least one bowel motion per week while taking usual laxatives
- Able to give informed consent
- Aged 18 or older
Who cannot join
- History declared by the candidate of other pre-existing gastrointestinal disorder, including but not limited to:
- Inflammatory Bowel Disease
- Coeliac Disease diagnosed in the last year
- Pancreatitis
- Cancer of the gastrointestinal tract
- Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
Show all 24Show fewer
- Presence of an intestinal stoma
- Pregnancy declared by candidate (no formal testing)
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Reported alcohol intake of >28 units/ week with daily drinking
- Any use of a product containing ispaghula or psyllium in the 4 weeks prior to consent
- Unable to avoid use of dihydrocodeine or morphine during the study
- If taking other regular opiates such as codeine, fentanyl or Oxycodone, participants should be able to maintain a stable dose throughout the study
- Any reported history of hypersensitivity or significant adverse reaction to ispaghula, maltodextrin or bisacodyl
- Unable to stop drugs and other agents used primarily for their laxative effect, during periods of screening, washout, baseline and treatment (maximum 15 days - rescue medication will be provided).
- Antibiotic or prescribed probiotic treatment in the past 4 weeks
- Inability to lie flat or exceed scanner limits of weight <120kg
- Poor understanding of English language
- Participation in any medical trials for the past 3 months
- Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
- Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD
- During the screening 2 weeks off laxatives
- No bowel motions recorded during screening period
- ≥3 complete spontaneous bowel motions (CSBMs - bowel motion with the feeling of complete evacuation, without the use of rescue therapy in the preceding 24 hours) per week
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
University of Nottingham
Nottingham, NG7 2UH
About this study
Official title: Validation of Magnetic Resonance Imaging to Characterise Gastrointestinal Physiology, Gut Luminal Content and Its Interaction With Colonic Microbiota in Patients With Chronic Constipation
The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the intestinal tract.
The investigators will also assess whether a change in gut bacteria and the chemicals that they release can be detected.
- Conditions
- Constipation
- Being tested
- Ispaghula, Maltodextrin
- Keywords
- Constipation, psyllium, ispaghula, Magnetic Resonance Imaging, MRI, microbiota
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IspaghulaDietary supplement
Also called psyllium
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Maltodextrin | Placebo comparator | 7 days without use of laxatives other than standardised rescue therapy 7 grams maltodextrin taken 3 times daily, at least 4 hours apart, for up to 7 days Receives: Dietary Supplement: Maltodextrin |
| Ispaghula | Active comparator | 7 days without use of laxatives other than standardised rescue therapy 7 grams ispaghula/ psyllium taken 3 times daily, at least 4 hours apart, for up to 7 days Receives: Dietary Supplement: Ispaghula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted Average Position Score of transit marker capsules as determined by MRI
After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position
Measured: 24 hours after ingestion
Secondary outcomes (11)
Weighted Average Position Score of 5 transit marker capsules, as determined by MRI
After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position
Measured: 48 hours after ingestion
Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI
Area under the curve (mL.min) will be calculated from hourly MRI scans
Measured: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Small Bowel Water Content (SBWC) in millilitres measured by MRI
After 5 days of taking the study product participants will undergo an MRI scan while fasted.
Measured: Baseline, 60 minutes before test meal
Ascending Colon Water Content in millilitres measured by MRI
After 5 days taking study product participants will undergo an MRI scan while fasted
Measured: Baseline, 60 minutes before test meal
Ascending Colon Water Content in millilitres measured by MRI
Area under the curve (mL.min) will be calculated from hourly MRI scans
Measured: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Change from baseline in Ascending Colon Water Content in millilitre measured by MRI
Difference between measurement Meal -60 (fasting) and Meal +60
Measured: test meal -60, test meal +60
Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI
Difference between time points Meal2 -20 and Meal 2 +40
Measured: test meal +360 minutes, test meal + 420 minutes
Ascending Colon T1
Area under the curve of MRI parameter measured at hourly time points
Measured: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Descending Colon T1
Area under the curve of MRI parameter measured at hourly time points
Measured: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Ascending colon T2
Area under the curve of MRI parameter measured at hourly time points
Measured: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Descending Colon T2
Area under the curve of MRI parameter measured at hourly time points
Measured: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, MSc MD FRCP, Study chair, University of NottinghamGiles Major, BM BCh MRCP, Principal investigator, University of NottinghamLuca Marciani, MSc PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144376
- Sponsor's protocol ID
- UON14011
- Other IDs
- 14GA006
- Acronym
- MIMIC
- Status last verified
- Jan 2017
- First submitted
- 25 Mar 2014
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Magnetic Resonance Imaging to Characterise Gastrointestinal Physiology, Gut Luminal Content and Its Interaction With Colonic Microbiota in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT02144376
- Acronym / sponsor ID
- MIMIC / UON14011
- Conditions
- Constipation
- Keywords
- Constipation, psyllium, ispaghula, Magnetic Resonance Imaging, MRI, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Ironwood Pharmaceuticals, Inc.
- Study start
- Mar 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 May 2014 (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 purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the intestinal tract.
The investigators will also assess whether a change in gut bacteria and the chemicals that they release can be detected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin7 days without use of laxatives other than standardised rescue therapy 7 grams maltodextrin taken 3 times daily, at least 4 hours apart, for up to 7 days |
| Ispaghula | Active comparator | Dietary Supplement: Ispaghula7 days without use of laxatives other than standardised rescue therapy 7 grams ispaghula/ psyllium taken 3 times daily, at least 4 hours apart, for up to 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets Rome III Criteria for diagnosis of Functional Constipation5 on questionnaire (NB. Both those who do and do not meet IBS criteria will be eligible)
- At least one bowel motion per week while taking usual laxatives
- Able to give informed consent
- Aged 18 or older
Key exclusion criteria (24 listed)
- History declared by the candidate of other pre-existing gastrointestinal disorder, including but not limited to:
- Inflammatory Bowel Disease
- Coeliac Disease diagnosed in the last year
- Pancreatitis
- Cancer of the gastrointestinal tract
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 |
|---|---|---|
| IspaghulaAlso: psyllium | Dietary supplement | Ispaghula |
| Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Weighted Average Position Score of transit marker capsules as determined by MRI
Time frame: 24 hours after ingestion
After 4 days of study product participants will ingest 5 transit mark capsules, the use of which has been shown to measure whole gut transit in a similar manner to more established techniques. They will continue to take study product before undergoing an MRI scan to assess capsule position
11 secondary outcomes
Weighted Average Position Score of 5 transit marker capsules, as determined by MRI
Time frame: 48 hours after ingestion
Small Bowel Water Content (SBWC) in millilitres(mL) measured by MRI
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Small Bowel Water Content (SBWC) in millilitres measured by MRI
Time frame: Baseline, 60 minutes before test meal
Ascending Colon Water Content in millilitres measured by MRI
Time frame: Baseline, 60 minutes before test meal
Ascending Colon Water Content in millilitres measured by MRI
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Change from baseline in Ascending Colon Water Content in millilitre measured by MRI
Time frame: test meal -60, test meal +60
Change from before to after challenge meal in Ascending Colon Water Content before in millilitre measured by MRI
Time frame: test meal +360 minutes, test meal + 420 minutes
Ascending Colon T1
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Descending Colon T1
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Ascending colon T2
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
Descending Colon T2
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal
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 5 Jan 2017.
- Individual participant dataSharing planned: No
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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, MSc MD FRCP study chair
University of Nottingham
Giles Major, BM BCh MRCP principal investigator
University of Nottingham
Luca Marciani, MSc PhD study director
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ispaghula and Maltodextrin in people with Constipation, run by University of Nottingham at 2 sites 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 4 inclusion and 24 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Weighted Average Position Score of transit marker capsules as determined by MRI (time frame: 24 hours after ingestion). 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 5 Jan 2017.