Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- small bowel water content
研究概览
简要总结
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.
详细描述
If participants interested to take part the investigators will ask some questions to check participants are eligible to take part. Part of this involves measuring height, weight and having an electrocardiogram (ECG) to assess the heart. This is non-invasive and is achieved by attaching stickers across participants' chest. If participants are eligible the investigators will invite them to join the study, asked to sign a consent form and arrange for them to come to 4 study days.
Study Days The study days take place at the 3T Acheiva MRI scanner at the Sir Peter Mansfield Imaging Centre. This is located on the University Park campus.
The day before each scanning day participants will be asked to eat and drink as normal, avoiding beans or pulses and abstain from alcohol. The investigators ask that participants avoid strenuous exercise, and if they smoke to continue as normal.
On the morning of the day 1 of the study participants should come to the MRI scanner around 8 o'clock in the morning. They should not have anything to eat or drink at all, unless they need a sip of water to swallow essential medicines. The investigators will confirm that it is still safe for participants to be scanned and participants will then change into surgical scrubs (provided) to begin the study.
Participants will be randomly assigned to take either ondansetron, the anti-sickness tablet, for the first 2 visits or a dummy tablet (placebo) three times daily. They will be overcoated tablets so that neither participants nor the research team can tell which one it is.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 or older
- •able to give informed consent
排除标准
- •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
研究组 & 干预措施
Ondansetron and lactulose
Ondansetron 8mg three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
干预措施: Ondansetron 8mg (Drug)
Ondansetron and lactulose
Ondansetron 8mg three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
干预措施: abdominal MRI (Diagnostic Test)
Ondansetron and lactulose
Ondansetron 8mg three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
干预措施: Lactulose (Drug)
Placebo and lactulose
placebo oral capsule, one three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
干预措施: abdominal MRI (Diagnostic Test)
Placebo and lactulose
placebo oral capsule, one three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
干预措施: Lactulose (Drug)
Placebo and lactulose
placebo oral capsule, one three times daily for 48 hours lactulose 20ml twice daily for 48 hours Serial abdominal MRI imaging
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
small bowel water content
时间窗: 0-6 hours post meal
Change from baseline in area under the curve (AUC) small bowel water content
次要结局
- small bowel motility (global motility score, arbitrary units)(2 and 4 hours postprandially)
- Weighted average position score (WAPS)(baseline on day 3)
- T1 of the ascending colon (T1AC)(baseline on day 3)