Evaluation of the Impact of a Fermented Milk Containing Lactobacillus Casei Strain Shirota on Stool Consistency, Stool Frequency, Constipation-related Symptoms and Quality of Life in People Who Frequently Have Hard or Lumpy Stools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements
研究概览
简要总结
The objective of this study is to evaluate if consumption of fermented milk containing Lactobacillus casei strain Shirota has an impact on stool consistency, stool frequency, constipation-related symptoms, and quality of life in subjects who frequently have hard or lumpy stools.
详细描述
Constipation is a common problem affecting approximately 17% of the general population in Europe. Several reports suggest that production of hard or lumpy stools (HLS) is strongly associated with the development of constipation. HLS are produced not only by chronic constipated patient but also by healthy population. Thus, reducing the incidence of HLS might be beneficial in terms of reducing the incidence of constipation in healthy population.
The results of two clinical studies conducted in Europe indicate the positive effect of fermented milk (FM) containing Lactobacillus casei strain Shirota (LcS) to modulate the hardness or dryness of stools. Koebnick et al. (2003) reported that consumption of the FM drink containing LcS decreased the occurrence of hard or lumpy stools, and improved the severity of constipation in patients with chronic constipation in Germany. An open trial conducted in Ghent, Belgium used commercially available FM containing LcS (Yakult® Light) in subjects who frequently had hard or lumpy stools, screened by an average Bristol Stool Form Scale (BS) score < 3.0. After 3 weeks of treatment, the proportion of subjects who produced hard or lumpy stools (BS score = 1 or 2) ≥ 25% of bowel movements decreased from 73.7% at baseline to 36.8%, while in the non-intervention control group the proportion increased from 75.0% to 85.0% during the same period. Based on the results of those studies, it was anticipated that LcS might assist in reducing the production of hard or lumpy stools in the general population. In order to confirm the efficacy in healthy population, a randomised, double blind, placebo control study is required.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •; a subject:
- •is informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and give written consent to participate in the study prior to the start of any study-related procedures
- •is healthy female or male, 18-65 years of age, inclusive
- •is conscious of having hard or lumpy stools in daily life
- •has an average Bristol Stool Form Scale score <3.0 per bowel movement
- •female subjects of childbearing potential should use a reliable method of contraception
排除标准
- •; a subject:
- •is under the age of legal consent
- •is mentally or legally incapacitated
- •is treated by a doctor for her/his constipation
- •has a history of gastrointestinal surgery except for appendectomy
- •has a history of chronic gastrointestinal diseases, including but not limited to inflammatory bowel diseases
- •has a severe gastrointestinal disorder
- •has clinically relevant medical conditions, e.g., renal, hepatic, pulmonary, cardiac, hematological, endocrinological, neurological, or psychiatric conditions
- •is pregnant or wanting to become pregnant during the course of the study
- •is unable to refrain from or anticipates the use of any medication (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and herbal supplements), except for paracetamol, oral contraceptives, or hormonal replacement therapy during the screening visit and for the duration of the study
- •has a history of drug and/or alcohol abuse
- •has milk allergies
- •is intolerant to lactose
研究组 & 干预措施
Fermented milk
Fermented milk containing Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.
干预措施: Fermented milk containing Lactobacillus casei strain Shirota (Dietary Supplement)
Placebo
Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements
时间窗: During pre-treatment (2 weeks) and treatment (8 weeks)
Hard or lumpy stools are defined as stools with Bristol Stool Form Scale score 1 or 2. Incidence of hard or lumpy stools is calculated by weekly basis.
次要结局
- Weekly number of spontaneous bowel movements(During pre-treatment (2 weeks) and treatment (8 weeks))
- Weekly average Bristol Stool Form Scale score(During pre-treatment (2 weeks) and treatment (8 weeks))
- Patient Assessment of Constipation Symptoms (PAC-SYM) score(6 points (Days 1, 15, 29, 43, 57 and 71))
- Patient Assessment of Constipation Quality of Life (PAC-QOL) score(6 points (Days 1, 15, 29, 43, 57 and 71))
- Weekly number of spontaneous complete bowel movements(During pre-treatment (2 weeks) and treatment (8 weeks))