The Effect of a Symbiotic LCA Yoghurt on Health-related Quality of Life and the Symptoms of Irritable Bowel Syndrome in Adults: A Randomized, Double-blind, Placebo Controlled, Multicentre Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Quality of life
研究概览
简要总结
This study evaluates the effect of a symbiotic fermented milk on health-related quality of life and irritable bowel syndrome (IBS) symptoms in patients with constipation-predominant IBS.
详细描述
Irritable bowel syndrome (IBS) is one of the most common digestive disorders in the developed world which. It is associated to numerous symptoms, of which the most characteristic are recurrent pain or discomfort in the abdominal region, changes and difficulties related to bowel movements, and bloating. Although not dangerous, the disease may significantly impair the patients' quality of life. Treatment is symptomatic, but currently not very efficient. The use of probiotics in the treatment of IBS is a promising approach and has been the subject of much research in the last two decades.
The purpose of this randomized, placebo-controlled study is to assess changes in health-related quality of life in patients with constipation-predominant IBS after regular consumption of symbiotic fermented milk (containing probiotics and dietary fibres) and to assess its effects on some symptoms, like abdominal pain or discomfort, bloating, and chronic constipation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed constipation-predominant irritable bowel syndrome (on the basis of Rome III criteria) (≥ 25 % lumpy or hard stools and ≤ 25 % mushy or watery stools).
- •Meeting Rome III criteria for the determination of irritable bowel syndrome in the last 6 months prior to inclusion and the presence of symptoms such as abdominal pain, bloating and general digestive discomfort at least twice a week in the last 3 months prior to inclusion.
- •Colonoscopy in the last 7 years prior to inclusion with normal results.
排除标准
- •Diarrhoea-predominant irritable bowel syndrome (≥ 25 % mushy or watery stools and ≤ 25 % lumpy or hard stools).
- •Clinical signs of alarm, such as rectorrhagia, fever, recent unexplained weight loss.
- •Organic gastrointestinal diseases, including chronic inflammatory bowel disease and systemic diseases with gastrointestinal difficulties.
- •Severe abdominal pain and the taking of analgesics or antispasmodics for the previous 5 days or more.
- •Having begun treatment with psychotropic medicines or other drugs for the treatment of irritable bowel syndrome within the previous month.
- •Dietary habits that could influence the assessment of the investigational product, such as slimming or a vegetarian diet.
- •Known allergy to ingredient(s) in the investigational product.
- •Known medical or psycho-physical condition that is, in the opinion of the investigator, in conflict with consumption of the investigational product and/or the course of the study.
- •Participation in another clinical study less than one month before inclusion or concurrent participation in another clinical study.
研究组 & 干预措施
Symbiotic
LCA symbiotic fermented milk, 180 g pot, twice daily.
干预措施: LCA symbiotic fermented milk (Other)
Placebo
heat-treated fermented milk, 180 g pot, twice daily.
干预措施: heat-treated fermented milk (Other)
结局指标
主要结局
Quality of life
时间窗: 4 weeks of product consumption
assessed by IBS-QoL questionnaire
次要结局
- Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)(2 weeks of product consumption)
- Quality of life(2 weeks of product consumption)
- Improvements in IBS symptoms (bloating, abdominal pain, satisfaction with bowel movement, stool frequency and stool consistency)(4 weeks of product consumption)