Effects of Fibre on Intestinal Volume and Gas in Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change from the baseline in colonic gas
研究概览
简要总结
The aim of the study is to investigate how dietary fibre combinations affects gut physiology, particularly colonic gas production. Comparisons will be made between a single fermentable fibre (inulin), a non-fermentable fibre (psyllium) and a combination of the two. The study will also explore differences in response between diarrhoea-predominant and constipation-predominant IBS (IBS-D and IBS-C) respectively.
The participants will have a preliminary meeting to ensure they are eligible, then will attend the MRI department on 4 occasions separated by at least 1 week. They will ingest a drink with the fibre product mixed in, and will have 8 MRI scans (each lasting approximately 15 minutes).
详细描述
The aim of the study is to investigate how dietary fibre combinations affects gut physiology, particularly colonic gas production. Comparisons will be made between a single fermentable fibre (inulin), a non-fermentable fibre (psyllium) and a combination of the two. The study will also explore differences in response between diarrhoea-predominant and constipation-predominant IBS (IBS-D and IBS-C) respectively.
This is a single-centre, 4-period, 4-treatment, placebo-controlled, crossover trial. Each treatment will be taken once by each participant, with randomisation of treatment order.
The staff responsible for preparing this food will be members of the digestive diseases unit at the NIHR Nottingham Biomedical Research Centre and will not be involved in the study otherwise. The investigators responsible for MRI and symptom analysis will be kept blind to the intervention as data will be coded by date of study day, rather than by product received. Additionally MRI data will be assigned a 'scanning number' through the Sir Peter Mansfield Imaging Centre. This will pseudo-anonymise MRI data within the study so that associations between participants and scans will not be immediately obvious.
Randomisation All participants will take all 4 fibre/ placebo preparations in this crossover trial but the order in which the participants take them will be randomised. The randomisation will be undertaken by a member of the research division who is independent of the study using the remote, online, open source software www.randomization.com. The resulting code will be retained by staff responsible for food preparation in paper form, and will not be shared with the investigator team. A paper copy will be kept by the CI in a sealed envelope.
On enrolment to the study, participants will be allotted the next available randomization sequence. No stratification is needed as in a crossover design participants act as their own controls. There will be a washout period of at least one week between each study day to minimise any carryover effect.
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
Participants will be blind to the fibre product taken on each study visit. Masking will be assisted by adding lemon juice to the vehicle drink.
The staff responsible for preparing this food will be members of the digestive diseases unit at the NIHR Nottingham Biomedical Research Centre and will not be involved in the study otherwise. The investigators responsible for MRI and symptom analysis will be kept blind to the intervention as data will be coded by date of study day, rather than by product received. Additionally MRI data will be assigned a 'scanning number' through the Sir Peter Mansfield Imaging Centre. This will pseudo-anonymise MRI data within the study so that associations between participants and scans will not be immediately obvious.
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •Fulfilment of the Rome IV criteria for Irritable Bowel Syndrome for at least 3 months:
- •Abdominal pain at least two or more days per week.
- •Pain associated with two or more of the following:
- •Related to defecation on at least ≥30% of occasions
- •Associated with a change in frequency of stool on ≥30% of occasions
- •Associated with a change in form (appearance) of stool on ≥30% of occasions
- •Symptom onset at least 6 months prior to diagnosis
排除标准
- •Pregnancy declared by candidate
- •Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- •Inability to lie flat or exceed scanner limits of weight <120kg
- •Unwilling to cease use of supplementary fibre or osmotic laxatives for the duration of the study
- •Unable to stop drugs known to alter GI motility or transit including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists or osmotic laxatives for 2 days before, and during, MRI study days.
- •Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria
- •Reported alcohol intake of >28 units/ week with daily drinking
- •Intention to change smoking behaviour during the study
- •History declared by the candidate of other pre-existing gastrointestinal disorders, including but not limited to:
- •Inflammatory Bowel Disease
- •Coeliac Disease
- •Pancreatitis
- •Gallstone disease (biliary colic, cholecystitis; asymptomatic presence of gallstones permitted)
- •Complicated diverticulitis (asymptomatic presence of diverticula permitted)
- •Cancer of the gastrointestinal tract
- •Gastroparesis
- •Other functional gastrointestinal disorders will be permitted as they frequently co-exist with IBS.
- •Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
- •Presence of an intestinal stoma
- •Poor understanding of English language
- •Participation of any medical trials for the past 3 months
- •Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD
结局指标
主要结局
Change from the baseline in colonic gas
时间窗: baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink
in arbitrary units measured by MRI
次要结局
- Change from the baseline in colonic volume(baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink)
- Change from the baseline in small bowel water content(baseline, 0, 1, 2, 3, 4, 5 and 6 hours post ingestion of the fibre drink)
- Change from the baseline in severity of pain, bloating and flatulence(baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink)
- Change from the baseline in breath hydrogen(baseline, 0mins, 30mins, 1 hour, 90mins, 2 hours, 3, 4, 5 and 6 hours post ingestion of fibre drink)