NCT01637714Unknown不适用
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change of Irritable bowel syndrome symptom severity score (IBS-SSS)
研究概览
简要总结
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willing to consent/undergo necessary procedures
- •between the age of 19 and 75 years
- •diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)
排除标准
- •uncontrolled hypertension (Blood pressure > 180/110 mmHg)
- •uncontrolled diabetes mellitus (FBS > 200 mg/dL)
- •malignancy, cerebrovascular disease, cardiovascular disease
- •history of abdominal surgery except appendectomy and hernia repair
- •inflammatory bowel disease
- •clinically or laboratory-confirmed gastroenteritis
- •the use of motility drug or dietary fiber supplement in 2 weeks
- •serum Cr > 2 x Upper normal limit
- •AST or ALT > 2 x Upper normal limit
- •Pregnancy, Lactating woman
研究组 & 干预措施
Multi-strain probiotics
Experimental
干预措施: Multi-strain probiotics (Drug)
Placebo powder
Placebo Comparator
干预措施: Placebo powder (Drug)
结局指标
主要结局
change of Irritable bowel syndrome symptom severity score (IBS-SSS)
时间窗: after 8 weeks
Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life
次要结局
- Stool frequency and form(after 4 weeks and 8 weeks)
- Improvement of overall symptom in patient with irritable bowel syndrome(after 4 weeks and 8 weeks)
- Symptom control of irritable bowel syndrome(after 4 weeks and 8 weeks)
- Assessment for patient satisfaction after administration completion(after 4 weeks and 8 weeks)
- Assessment for quality of life related with irritable bowel syndrome(after 4 weeks and 8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Determination of the Safety and Efficacy of Two Probiotic StrainsGastrointestinal DysfunctionNCT06466174The Archer-Daniels-Midland Company100
已完成
不适用
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated AppendicitisAppendicitisPerforation AppendicitisNCT04529980Children's Health98
已完成
不适用
Probiotics in Elderly Patients With Medical ConditionsAgingMulti-Core DiseaseConstipationNCT04035616Universiti Kebangsaan Malaysia Medical Centre100
Unknown
不适用
Antipsychotic Effects of Probiotics and Prebiotics on Patients With SchizophreniaSchizophreniaNCT04291469First Affiliated Hospital Xi'an Jiaotong University200
已完成
不适用
The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal SymptomsAntibiotic-associated DiarrheaNCT05845073The Archer-Daniels-Midland Company69