NCT01268618终止2 期
A Double-blind, Randomized, Placebo-controlled, Dual-center Study on the Effect of Healthy Trinity (Retail Label)/Trenev Trio (Professional Label) on Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) and Functional Dyspepsia
Sprim Advanced Life Sciences4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Abdominal pain severity
研究概览
简要总结
Primary Objective:
• To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia
Secondary Objective:
• To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 75 years
- •Diagnosed with IBS-D including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of Bristol Stool form of ≥6 on a 1-7 scale
- •Diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning AND no evidence of structural disease that is likely to explain the symptoms
- •History of IBS-D and dyspepsia symptoms for at least 12 weeks
- •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
- •Successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires
排除标准
- •Major gastrointestinal complication, e.g. Crohn's disease or ulcer
- •Prior abdominal surgery with the exception of hernia repair and appendectomy
- •Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years
- •Clinically significant systemic disease
- •Life expectancy < 6 months
- •Pregnant female or breastfeeding
- •Lactose intolerance
- •Immunodeficient subjects
- •Anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years
- •Systemic steroids within the prior month
- •Current treatment with nasogastric tube, ostomy, or parenteral nutrition
- •Use of proton pump inhibitors
- •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
结局指标
主要结局
Abdominal pain severity
时间窗: 8 weeks
Stool consistency (Bristol Stool Chart)
时间窗: 8 weeks
Dyspepsia Symptom Severity Index (DSSI)
时间窗: 8 weeks
次要结局
- Proportion of subjects with 1 or more adverse events(8 weeks)
研究者
研究点 (4)
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