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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
University of Nottingham
Nottingham, United Kingdom
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
Time frame: 24 hours after ingestion
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
Time frame: 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
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
After 5 days of taking the study product participants will undergo an MRI scan while fasted.
Time frame: 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
Time frame: 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
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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
Difference between measurement Meal -60 (fasting) and Meal +60
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
Difference between time points Meal2 -20 and Meal 2 +40
Time frame: test meal +360 minutes, test meal + 420 minutes
Ascending Colon T1
Area under the curve of MRI parameter measured at hourly time points
Time frame: -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
Time frame: -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
Time frame: -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
Time frame: -60, 0, 60, 120, 180, 240, 300, 360, 420 minutes after test meal