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临床试验/NCT02953171
NCT02953171Unknown不适用

A Randomized Controlled Clinical Trial to Investigate the Efficacy of Lacto-fermented Sauerkraut and the Probiotic E. Coli Nissle 1917 in the Treatment of Irritable Bowel Syndrome

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
140
试验地点
1
主要终点
IBS Symptom Severity Scale (IBS-SSS).

研究概览

简要总结

The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.

详细描述

Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects around 11% of the population globally. Several factors have been implicated in the pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet. More recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional GI condition.

Gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of IBS. However, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of IBS. Many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent.

Several studies have investigated how the use of probiotic supplements containing Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria, are useful in the treatment of IBS. Moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus Escherichia, affect symptoms of IBS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis):
  • Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following:
  • Improvement with defecation
  • Onset associated with a change in frequency of stool
  • Onset associated with a change in form (appearance) of stool

排除标准

  • Psychiatric disorder
  • Metabolic disease
  • Chronic infection
  • Organic gastrointestinal disorder
  • Pregnancy
  • Breastfeeding

研究组 & 干预措施

Raw sauerkraut+Probiotic capsule

Experimental

75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

干预措施: Raw, lacto-fermented sauerkraut (Other)

Raw sauerkraut+placebo capsule

Experimental

75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.

干预措施: Raw, lacto-fermented sauerkraut (Other)

Raw sauerkraut+placebo capsule

Experimental

75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.

干预措施: Placebo capsule (Other)

Pasteurized sauerkraut+Probiotic capsule

Experimental

75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

干预措施: Pasteurized sauerkraut (Other)

Pasteurized sauerkraut+Placebo capsule

Placebo Comparator

75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.

干预措施: Pasteurized sauerkraut (Other)

Pasteurized sauerkraut+Placebo capsule

Placebo Comparator

75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.

干预措施: Placebo capsule (Other)

Pasteurized sauerkraut+Probiotic capsule

Experimental

75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

干预措施: Mutaflor (Dietary Supplement)

Raw sauerkraut+Probiotic capsule

Experimental

75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

干预措施: Mutaflor (Dietary Supplement)

结局指标

主要结局

IBS Symptom Severity Scale (IBS-SSS).

时间窗: Change from day 0 to day 42

次要结局

  • Body weight(Change from day 0 to day 42)
  • The Quality of Life Scale (QOLS)(Change from day 0 to day 42)
  • Fecal microbiome diversity(Change from day 0 to day 42)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eirik Garnås

Public Health Nutritionist

University of Copenhagen

研究点 (1)

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