Constipation remains an important unmet medical need. Patients are currently often dissatisfied with treatment, because of lack of predictability of the laxative, side effects (mainly abdominal pain) and perceived decrease of efficacy with time. A recent systematic review of a range of laxatives reported that bisacodyl increases the number of complete spontaneous bowel movements statistically significant compared to placebo. Recently non-invasive Magnetic Resonance Imaging (MRI) techniques have been developed to assess small intestinal fluid distribution, transit and motility as well as colonic fluid, volumes and motility in healthy volunteers and constipated subjects. Other laxatives such as movecol and ispaghula have been investigated using this methodology. This study will use these novel techniques to further characterize bisacodyl's mode of action. This study is intended to assess the effect of a single-dose of bisacodyl on the gut motor function and its effect on water distribution within the small and large intestine in subjects with occasional constipation by MRI. It may allow better understanding of the relative importance of both the secretory and the prokinetic effect of bisacodyl. Since bisacodyl is often used by self-medicating people with constipation it is proposed to study subjects suffering from occasional constipation. As such subjects often take the drug intermittently it would be of interest to study both the acute response after single dose and the response after several days of treatment to see if this alters the response. The current study will be performed as a cross-over with 2-period and 2-treatment (bisacodyl/placebo), for assessing the effects over of a single-dose of 5mg bisacodyl. Evaluations will be performed after one single dose of bisacodyl or placebo in two different time periods, separated by a 2 week washout period between end of period 1 and start of period 2. The study will recruit individuals ≥18yrs from the general public who consider themselves as suffering from occasional constipation and who self-medicate with an occasional over-the counter (OTC) laxative, not more than once a week. Up to 18 adult healthy subjects will be recruited to ensure 10 evaluable subjects. An evaluable subject is defined as participant having the primary endpoint assessed (ascending colon T1 300, 375, and 450 minutes correctly evaluated) for the two periods of the crossover.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
12
one single dose
one single dose
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom
Consistency of chyme in ascending colon
as measured by MRI (T1)
Time frame: Area under the curve 300-450 minutes after single intake of intervention
Longer term consistency of chyme in ascending colon
as measured by MRI (T1)
Time frame: 24 hours after drug intake
Gut motor function
colonic and small bowel motility as measured by MRI
Time frame: 0-150 and 150-450 minutes after single intake of intervention
Small intestinal water content
as measured by MRI
Time frame: 0-150 and 150-450 minutes after single intake of intervention
Colon volumes
as measured by MRI
Time frame: 0-150 and 150-450 minutes after single intake of intervention
Speed of whole gut transit
weighted average position score of transit markers
Time frame: at 450 minutes and 24 hours after transit marker and study drug intake
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