Randomized Controlled Trial of Probaclac Versus Placebo in Children Aged 8 to 18 Years With Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Subjective assessment of improvement of symptoms
研究概览
简要总结
The aim of this study is to determine the efficacy of the administration of Bifidobacterium bifidum R0071, Bifidobacterium longum R0175, Lactobacillus helveticus R0052, Lactobacillus Delb. SSP bulgaricus R9001, Lactobacillus rhamnosus R0011, Lactococcus Lactis SSP. lactis R1058 et Streptococcus thermophilus (Probaclac™) given twice a day for 4 weeks on digestive symptoms evaluated subjectively in children aged 8 to 18 years with irritable bowel syndrome versus placebo.
This study is a double-blind randomized controlled study. 84 children will included. After inclusion, a 15-day period of observation precedes the randomization at Day 0. Patients receive Probaclac or placebo for 4 weeks. At the end of the treatment period, patients are followed for a 2-week period of follow-up.
4 visits and 4 phone calls are planned during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 8 to 18 years
- •Irritable bowel syndrome according to Rome III criteria
排除标准
- •Not able to collaborate
- •Known Digestive malformation
- •History of digestive surgery (except hernia repair and appendectomy)
- •History of known digestive disease (Crohn's, ulcerative colitis, esophagitis, peptic ulcer, celiac disease)
- •Symptoms suggestive of organic disease (such as rectal bleeding, weight loss
- •History of chronic extra-digestive disease
- •Acute gastroenteritis in th e4 weeks prior to inclusion
- •Central catheter, artificial cardiac valve, endocardiac prothesis
- •Current Antidepressant treatment
- •Patients taking a treatment for irritable bowel syndrome unable to cease their current treatment
- •Patient taking regularly probiotics and natural products
结局指标
主要结局
Subjective assessment of improvement of symptoms
时间窗: 4 weeks
次要结局
- Change in severity of symptoms (likert scale)(4 weeks)
- Presence or absence of urgency, incomplete evacuation, gas(4 weeks)
- Presence and intensity of pain episodes(4 weeks)
- Adverse Events(2 months)
- Number and consistance of the stools(4 weeks)
- Quality of Life(4 weeks)
- School and social absenteism(4 weeks)
研究者
Christophe Faure
MD
St. Justine's Hospital