NCT02108119已完成2 期
The Effect of Probiotics on Symptoms and Intestinal Flora in Patients With Irritable Bowel Syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Abdominal pain
研究概览
简要总结
To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide informed consent
- •Age ≥18 and ≤70 years at Visit 1
- •IBS according to the Rome III criteria
- •A score on abdominal pain NRS ≥3 and ≤6 at least two days a week measured the weeks before Visit 2 (baseline)
- •IBS-SSS ≥75 and ≤300 at Visit 2 (baseline)
- •Ability and willingness to understand and comply with the study procedures
排除标准
- •Known intolerance or allergy to milk products (protein or lactose) or gluten
- •History of alcohol or substance abuse six months prior to screening
- •Known Hepatitis B or C or Human Immunodeficiency Virus (HIV) 1 or 2
- •Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
- •Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the Investigator
- •Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the Investigator
- •Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the Investigator
- •Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the Investigator
- •Severe psychiatric disease as judged by the Investigator
- •Lack of suitability for participation in the study for any reason as judged by the Investigator
- •Use of other probiotic products from Visit 1 and throughout the study.
- •Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
- •Consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the Investigator.
结局指标
主要结局
Abdominal pain
时间窗: 28 days
0-10 numeric rating scale (NRS)
次要结局
未报告次要终点
研究者
研究点 (2)
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