Effect of an Enriched Butyrogenic Fibres Diet on Rectal Sensitivity in Healthy Control and IBS Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Discomfort threshold to rectal distension
研究概览
简要总结
Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.
详细描述
Despite there being no clearcut advantages, one of the most common recommendations in IBS management is to increase the amount of dietary fibres. In some IBS patients fibres have a deleterious effect on pain and bloating. It has been shown that butyrate can increase colonic sensitivity in rats. Our purpose is to study whether butyrogenic fibres can modify rectal sensitivity and symptoms in IBS and healthy control through a modification of colonic flora.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged 18-60 years
- •Normal volunteers and patients with IBS assessed by Rome II criteria
- •Effective contraception
- •Affiliated to National Health Service
- •Having received oral and written information about the study
- •Having provided her written informed consent
排除标准
- •Significant clinical or biological abnormality
- •Organic gastrointestinal disease
- •Subjects having lower than 15g/day or higher than 20g/day fibres intake
- •Antibiotic treatment during the month preceding the pre inclusion day
- •Antispasmodics, antidiarrheics, laxatives, and prokinetics during the week preceding the pre inclusion day and during all the study period.
- •Digestive surgery tract except appendectomy and cholecystectomy
- •Alcohol abuse
- •Drug addiction
- •Major psychiatric disorder
结局指标
主要结局
Discomfort threshold to rectal distension
次要结局
- Quality of life (questionnaire)
- Functional composition of colonic flora
- Rectal sensitivity : first sensation and threshold for first sensation of the need to defecate.
- Taxonomic composition of colonic flora
- Fermentation profile of ingested fibre
- Intestinal discomfort (questionnaire)