None listed
Conditions
Brief summary
Gastrointestinal hypomotility ("slow gut") caused by clozapine is common, important and poorly understood. It causes distress and even sudden death. It may affect more than half of clozapine treated patients, but there are no clinically reliable signs and symptoms to identify it. One in 500 clozapine treated patients die from druginduced bowel obstruction. Segmental gastrointestinal transit times (e.g. gastric and small bowel emptying) of clozapine treated patients have never been quantified. This is an extension of a previous study which used radiopaque markers to explore gastrointestinal transit time in clozapine treated patients. These results showed very abnormal bowel function, but data were crude and limited to the colon. This study involves similar methodology, but a more sensitive measurement technique -a wireless motility capsule -which will provide more data and add to the understanding of this problem. Wireless motility capsules ('smartpills') are vitamin-pill sized capsules. When swallowed they offer an ambulatory, safe, minimally invasive and validated assessment of intraluminal pH, temperature, and pressure during their transit through the gastrointestinal (GI) tract. There is no radiation exposure to the patient. This technology allows for accurate measurement of transit times in multiple regions of the upper and lower GI tract. benefit them individually, as well as informing the evidence base.
Interventions
The exposure is clozapine treatment. The condition observed is gastrointestinal transit times (gastric emptying, small bowel transit, colon transit) as measured by wireless motility capsule (WMC). After fasting overnight, the participant consumes a small standardised meal (Smartbar) then ingests a wireless motility capsule (Smartpill) which is equipped with temperature, pH, and pressure monitoring devices. The participant wears a recording device. They do not eat over the next 6 hours to captu
The exposure is clozapine treatment. The condition observed is gastrointestinal transit times (gastric emptying, small bowel transit, colon transit) as measured by wireless motility capsule (WMC). After fasting overnight, the participant consumes a small standardised meal (Smartbar) then ingests a wireless motility capsule (Smartpill) which is equipped with temperature, pH, and pressure monitoring devices. The participant wears a recording device. They do not eat over the next 6 hours to capture gastric emptying times. They then eat and drink as normally. Bowel motions are noted by the participant pressing an event button on the data recorder. The WMC will transit through the gastrointestinal tract relaying data telemetrically to the recorder. The WMC ends up being expelled in the faeces and is single use only. The data receiver will be worn for 96 hours post capsule ingestion. At t=96 we will check the data output to confirm whether the WMC has been expelled. If it is still recording, the participant will wear it for a further three days. The study will be terminated at t=168 hours
Sponsors
Susanna Every-Palmer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Competent and consenting adult (>18) patients prescribed clozapine (any dose) residing in a specific New Zealand low-secure mixed rehabilitation facility
Exclusion criteria
Not competent to consent Participant takes laxatives and prefers to continue taking them during study period or their treating team has concerns about them having a laxative holiday (laxatives would cause spurious transit times) Insulin dependent diabetics History of: (a) GI surgery in the last 3 months (b) Crohn’s disease or diverticulitis (c) implanted electromechanical device (i.e a cardiac pacing device or cochlear implant) (d) gastric bezoar (e) swallowing disorder (f) suspected or known stricture or fistula (g) physiological/ mechanical GI obstruction
Outcome results
None listed