A Randomised, Double-blind, Placebo-Controlled, Parallel Study to Evaluate the Effects of Lepicol® in Adults With Chronic, Functional Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of bowel movements per week
研究概览
简要总结
Constipation is common in the general population, especially in women and in the elderly. Hard stool is a complaint often associated with constipation, which suggests that stool softening would provide a major benefit in the strategy of treatment.
This investigative fibre product is primarily a soluble dietary fibre with added probiotics and a prebiotic. It is not digested in the small intestine and partly remains undigested by bacteria in the gut. Also, as probiotics are believed to help restore a healthy gut flora, reduce pH, assist with digestion of food and reduce gaseous by-products they may aid the improvement of intestinal motility.
The objective of this study is to assess if this investigative, fibre product effects the number of bowel movements per week and if this in turn impacts quality of life and symptoms of constipation.
详细描述
Constipation is a common condition. Perception of a healthy bowel movement varies widely within and among populations but the Rome III Criteria is a standardised tool that diagnoses functional constipation on the basis of the following symptoms for the last 3 months with symptom onset at least 6 months prior to diagnosis:
- Must include two or more of the following:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations
- Manual manoeuvres to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three defecations per week
- Loose stools are rarely present without the use of laxatives
- Insufficient criteria for irritable bowel syndrome
Additional to being extremely uncomfortable, untreated constipation can lead to faecal impaction (with resulting faecal incontinence), particularly in elderly and confused people and is believed to be a risk factor for haemorrhoids (piles) and diverticular disease. However even without a medical diagnosis the undesired symptoms can reduce perceived quality of life and successful management may involve a number of factors. Standard treatment consists of disimpaction and the administration of laxatives to achieve a normal bowel habit of passing a soft stool without pain. The daily use of laxatives long term is often advised against as it can make your body dependent on them, causing your bowel to no longer function normally.
Stool softening is a physician's first step in the management of chronic constipation. Psyllium has been shown to soften stools by increasing stool water content, far more than most common dietary fibres. It forms a soft gel which eases the stool along the lower digestive tract ready for evacuation. This bulkier faeces presses on the wall of the intestine, stimulating the muscles to contract and force the contents forward, a process known as 'peristalsis'. If there is insufficient fibre in the diet, the faeces will move more slowly and there will be more time for water to be absorbed from the ingested food into the rest of the body, leaving the faeces smaller and harder, which in turn is more difficult to move. Psyllium has the advantage of being much gentler than some common fibres (such as wheat bran) that can be irritating to a sensitive bowel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be considered eligible for enrolment into the study, subjects must;
- •Be able to give written informed consent,
- •Be between 18 and 80 years of age,
- •Subject has chronic functional constipation according to the Rome III Diagnostic Criteria, where (f) is mandatory.
- •i. Must include two or more of the following:
- •Straining during at least 25% of defæcations
- •Lumpy or hard stools in at least 25% of defæcations
- •Sensation of incomplete evacuation for at least 25% of defæcations
- •Sensation of anorectal obstruction / blockage for at least 25% of defaecations
- •Manual manœuvers to facilitate at least 25% of defæcations (e.g., digital evacuation, support of the pelvic floor)
- •Fewer than 3 defæcations per week ii. Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months, with symptom onset at least 6 months prior to diagnosis
- •Subjects will continue on his/her normal diet,
- •The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study.
排除标准
- •Subjects will be excluded from the study if they meet any of the below criteria;
- •Are less than 18 and greater than 80 years of age,
- •Females are pregnant, lactating or wish to become pregnant during the study.
- •Are hypersensitive to any of the components of the test product,
- •Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study,
- •Subject has an obstructive or metabolic aetiology for constipation,
- •Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
- •Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit,
- •Subject has a history of drug and/or alcohol abuse at the time of enrolment
- •Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial,
- •Subjects may not be receiving treatment involving experimental drugs,
- •If the subject has been in a recent experimental trial, these must have been completed not less than 90 days prior to this study.
- •Have a malignant disease or any concomitant end-stage organ disease
研究组 & 干预措施
Natural Fibre Supplement
2 doses per day for 4 weeks
干预措施: Natural Fibre Supplement (Dietary Supplement)
Placebo
2 doses per day for 4 weeks
干预措施: Natural Fibre Supplement (Dietary Supplement)
结局指标
主要结局
Number of bowel movements per week
时间窗: 4 weeks
次要结局
- Stool consistency, as measured by the Bristol Stool Form Scale(4 weeks)
- Quality of life as measured by the Quality of Life Questionnaire (PAC-QOL)(4 weeks)
- Constipation symptoms as measured by PAC-SYM(4 weeks)
- Laxative use by subjects with functional constipation(4 weeks)