Association Between GI Microbiota, Low-grade Inflammation and Classical Pathophysiological Factors in Patients With Irritable Bowel Syndrome (IBS) and Effect of the Consumption of Activia on GI Symptoms Provoked by a Lactulose Challenge Test in IBS Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- IBS symptoms
研究概览
简要总结
The purpose of this study is to investigate the association between gut microbiota, immunology and typical pathophysiological factors in patients with IBS (all subtypes) AND to assess the effect of Activia consumption on GI symptoms provoked by a lactulose challenge test in IBS patients.
详细描述
BACKGROUND
There is a wide variety of symptoms in IBS, irritable bowel syndrome, both among individuals and in the symptoms of a specific individual. Pathophysiological factors that are of importance have been identified in IBS, but all of the factors do not occur in the symptomatology of all patients. Visceral hypersensitivity, deviant motor and secretion function in the gastrointestinal tract as well as psychological factors are believed to be of importance. However the relative importance of specific factors in the symptomatology is not elucidated.
Deviations in the autonomic and central nerve function have also been demonstrated in IBS, along with low grad inflammation, immunological anomalies, and changes in the microbiological gut flora. The importance of these factors in developing the more established pathophysiological factors, visceral hypersensitivity, and deviated gastrointestinal motor and secretion functions have not yet been studied. Neither have the interactions between the autonomic and central nerve functions or the significance of these functions in IBS.
In response to the recent findings, regarding deviant microbiological gut flora in IBS, the use of probiotics as treatment has been tested, with altering outcome. The effects of some products are positive, but far from all the patients with IBS get sufficient relief. The response of treatment with probiotics cannot be predicted with the methods available today; in example it is not possible to predict which patient will respond to the treatment and what the mechanisms behind the symptom relief are.
Questions
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
- 是
入选标准
- •Signed written informed consent
- •Age: between 18 and 65 years old at baseline visit
- •IBS according to the Rome III criteria
- •Ability to understand and willingness to comply to the study procedures
排除标准
- •Participation in another clinical study 1 month prior to screening visit and throughout the study
- •Abnormal results on the screening laboratory tests clinically relevant for study participation
- •Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
- •Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
- •Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
- •Severe psychiatric disease
- •Previous history of drug or alcohol abuse 6 months prior to screening
- •Intolerance or allergy against milk products or gluten
- •Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study
- •Consumption of antibiotics 1 month prior to screening and throughout the study
- •Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study
- •Pregnant or lactating or wish to become pregnant during the period of the study
结局指标
主要结局
IBS symptoms
时间窗: 8 Weeks
次要结局
未报告次要终点
研究者
Magnus Simrén
Professor
Sahlgrenska University Hospital, Sweden