Effect of Lactobacillus Acidophilus CL1285®, L. Casei LBC80R® and L. Rhamnosus CLR2® on Symptoms of Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 6
- 主要终点
- IBS Adequate Relief (IBS-AR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.
详细描述
Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Subject meets Rome III criteria for IBS (regardless of IBS subtype) as follows:
- •Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with 2 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
- •Symptom onset must be at least 6 months prior to diagnosis
- •Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- •Able to understand the nature and purpose of the study including potential risks and side effects
- •Willing to consent to study participation and to comply with study requirements
- •Abdominal pain or discomfort at least 2 days during run-in period associated with 2 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
- •Completion of all study-related questionnaires
排除标准
- •Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer
- •Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
- •Any systemic disease that may confound IBS symptoms or compromise subject safety
- •Life expectancy < 6 months
- •Pregnant female or breastfeeding
- •Lactose intolerance
- •Immunodeficient subjects
- •Uncontrolled psychiatric disorder
- •Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- •Eating disorder
- •Recent (< 2 weeks) antibiotic administration
- •History of alcohol, drug, or medication abuse
- •Daily consumption of probiotics, fermented milk, and/or yogurt
- •Known allergies to any substance in the study product
- •Participation in another study with any investigational product within 3 months of screening
研究组 & 干预措施
Probiotic capsules
L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks.
干预措施: L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® (Dietary Supplement)
Placebo capsules
The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria. Dosage of 2 capsules per day , corresponding to 100 billions bacterias for a period of 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
IBS Adequate Relief (IBS-AR)
时间窗: 12 weeks
The IBS-AR is a single-question dichotomous (yes/no) tool that asks subjects if they have experienced adequate relief of IBS symptoms over the past week.
次要结局
- IBS Symptom Severity Scale(12 Weeks)
- Concomitant medication use(12 Weeks)
- Stool Consistency(12 Weeks)
- Stool frequency(12 Weeks)
- IBS Global Assessment of Improvement Scale(12 weeks)
- IBS Quality of Life(12 Weeks)
- Abdominal Pain(12 Weeks)
- Adverse Events(12 Weeks)