Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea

• Status: Completed
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, two period, two treatment crossover trial of ondansetron verses placebo studying the effects of ondansetron in the small and large bowel, specifically its effects on the amount of water in the gut, measured by MRI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nottingham
• Treatments: Lactulose; Ondansetron

Criteria

Inclusion Criteria:

• aged 18 or older

• able to give informed consent

Exclusion Criteria:

• Pregnancy declared by candidate

• History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function, congenital long QT syndrome or QTc >450msecs for males or 470 msecs for female on screening ECG.

• A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire

• Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)

• Intestinal stoma

• Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products

• Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury

• Will not agree to dietary restrictions required during the MRI study day

• Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)

• Inability to lie flat or exceed scanner limits of weight <120kg

• Poor understanding of English language

• Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM

• Participation in any medical trials for the past 3 months

• Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse