Colonic Motility And Gut Microbiota Composition In Constipation And Ageing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total colonic transit time
研究概览
简要总结
The reason chronic constipation (CC) becomes commoner with age is not fully understood. New studies suggest that bowel contraction patterns, dietary fibre and gut bacteria are important and may differ in older people. Since CC reduces quality of life and is a major reason why elderly are admitted to hospitals and residential care, there is a need to understand how these factors change with age.
Currently, placing a pressure sensing catheter inside the large intestine (pancolonic manometry) is the gold standard way to measure how well it contracts. However this involves a camera test (colonoscopy) which is invasive with risks of bowel perforations (~80/100,000). The risk is higher with age (64-80yr: ~90/100,000; 80+yrs: ~120/100,000), making it unethical for elderly.
A technique called the 3D-Transit System has been developed, involving a small ingestible capsule, containing a 'trackable' electromagnet. By tracking movements of the capsule swallowed by participants, it provides precise detailed information on the capsule progression inside the whole gut and large bowel's contractile activity in real-time. It is minimally-invasive and radiation-free, making it possible to assess elderly for the first time.
This study aims to assess how bowel contraction patterns, dietary fibre intake and gut bacteria differ between young and older adults (with and without CC), to better understand why CC is more common in elderly.
It is a pilot, 4 arm, single centre, observational study involving 60 women aged 18-40 years and 70-90 years (15 non-constipated and 15 with CC for each age group). The study lasts 3 weeks, containing 2 weeks of run-in period and 1 week of study period.
The four groups participants will be asked to: swallow 2 capsules to assess their large bowel's contractile function using the 3D-transit system; provide stool samples to analyses their gut bacteria; and complete questionnaires to assess their gastrointestinal symptoms.
详细描述
Type of study Experimental study comparing colonic contractile functions (including region-specific gut transit times) between healthy young vs. older women, and between constipated young women vs. constipated older women
Design 4-arm observational pilot study
Study Population The study will include 15 healthy young women, 15 healthy older women, 15 young women with chronic constipation and 15 older women with chronic constipation (but otherwise healthy). Vulnerable subject groups (e.g. elderly with dementia) will not be included.
Subject Recruitment Participants with constipation will be identified mainly from the existing database of patients with constipation who had previously participated in research or undertaken anorectal physiology investigations at the GI physiology unit (part of Queen Mary University of London). [The GI physiology unit is part of an academic institution (Queen Mary University of London) and not part of the NHS. However being a specialised centre for anorectal physiological assessments, it investigates patients referred from various NHS sites throughout the UK. Thus it has built up a database of individuals with constipation who had previously undergone anorectal examinations and/or research]. Suitable participants will be identified by the Director (also Chief Investigator for this study) and staff of the GI physiology unit, who have access to the database and patients' medical records and personal data. Following identification, an invitation letter (containing the research team's contact details) will be sent to patients by the director of the unit (see supporting document). Potential participants with constipation will also be recruited via advertisement.
Participants without constipation will be recruited using mailing lists of public involvement groups. Participants will also be recruited through advertisements, posters, and/or websites in local media, social media, websites, academic institution, medical institutions and GP surgeries. The same text and layout will be used for all forms of advertising.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Inability to understand written and spoken English
- •Lacking capacity to understand subject information sheet and give informed consent
- •Vulnerable subject groups (e.g. elderly with dementia)
- •Pregnancy, intention to become pregnant, or breastfeeding during study period
- •Recent childbirth in the last 6 months
- •Other causes of reduced / dysregulated GI motility and secondary constipation
- •Conditions which make it unsafe to use the capsules
结局指标
主要结局
Total colonic transit time
时间窗: 2 to 5 days
Colonic transit time as measured by 3D transit system
次要结局
未报告次要终点