A Multi-center Human Study to Evaluate the Efficacy and Safety of ®GI Flora in Subjects With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 主要终点
- Visual Analogue Scale for abdominal pain
研究概览
简要总结
A Multi-center, Randomized, Double-blinded, Placebo-controlled Human Study to Evaluate the Efficacy and Safety of probiotic mixture(®GI Flora) in Subjects with Irritable Bowel Syndrome.
Regimen: 6 probiotics mixture >10^9/D for 8 weeks
Primary variable: visual analogue scale(VAS) assessment for abdominal pain
Secondary variable:
- change of VAS score for abdominal pain/discomfort after 4/8-week treatment
- daily symptom score for bloating, defecation discomfort(strain/urgency/incomplete evacuation), flatulence , feces shape, frequency of bowel movements
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable bowel syndrome patients according to Rome III criteria
- •Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
排除标准
- •Intolerable or hypersensitive to GI Flora.
- •Patients with active colon diverticulitis.
- •History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation.
- •History of inflammatory bowel disease, malignancy requiring surgery or chemotherapy or radiation within 5 years.
- •Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.
研究组 & 干预措施
GI Flora
Lactobacillus acidophilus LA1 1.312% Lactobacillus rhamnosus LR5 0.656% Lactobacillus paracasei LPC5 0.656% Bifidobacterium lactis BL3 1.312% Bifidobacterium breve BR3 1.312% Pediococcus pentosaceus SL4 1.312% Prolac-T(heat-killed L. acidophilus LA1) 24.286% Dextrose 60.000% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
干预措施: GI Flora (Dietary Supplement)
placebo
Dextrose 89.846% Maltodextrin 7.154% Lemon flavor 1.000% Mg-stearate 1.000% TOTAL 100% (1.4g)%
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Visual Analogue Scale for abdominal pain
时间窗: 8 weeks
次要结局
未报告次要终点