A Randomized Controlled Trial of Lactobacillus Rhamnosus Strain GG for The Prevention of Functional Abdominal Pain Children After Acute Gastroenteritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Prevention of Abdominal pain
研究概览
简要总结
The present study has several aims:
- Establish whether Lactobacillus Rhamnosus Strain GG is able to prevent the onset of IBS in a high risk group of children enrolled after an acute gastroenteritis (the study has been powered to this aim).
- Establish whether Lactobacillus Rhamnosus Strain GG is able to stabilize the intestinal microbiota after an acute gastroenteritis.
- Define the intestinal microbiota of children following an acute gastroenteritis and identify, if possible, a modification of the microbiota that can predict the emergence of Irritable Bowel Syndrome.
详细描述
Study Design A randomized, double-blind, placebo-controlled, parallel-group trial planned following the recommendations established by the Consensus report on clinical trial in IBS.
Children during/after an acute episode of gastroenteritis will enter a 12 months treatment (m1-m12) period followed by a 6 months follow-up phase (m13-m18).
Children will be assigned consecutive numbers, starting with the lowest number available, and randomly assigned, with the use of a computer generated randomisation list using permuted block design, to receive orally either LGG (6 × 109 colony forming units) or placebo (capsules identical in taste and appearance to the active study product except for the absence of LGG) once a day. Enrolled children will be entered sequentially to receive the assigned treatment. Boxes containing placebo will have the same shape, dimension, indication and appearance as those containing the viable LGG and will be provided by the probiotic producer (Dicofarm SpA, Rome, Italy) which ensure that the study is blinded for investigators and patients. Group assignment will be concealed from participants and investigators.
Power calculation With the assumption that, in a 12 month period, IBS would be expected in 16% of children after an episode of acute gastroenteritis as opposed to 5% in the general paediatric population without gastroenteritis, we calculated that a sample of 210 children per group would be required for the study to have 80% power to show an advantage of LGG over placebo in reducing the rate of IBS, based on a two-sided type 1 error rate of 5%..
Eligibility of Patients Patients recruited from primary care paediatricians or paediatric wards during/after (less seven days) an episode of gastroenteritis (bacteria/viruses/parasites).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of 3 - 16 years of age;
- •Either sex.
排除标准
- •Chronic disease,
- •Clinical history of abdominal pain history suggestive for functional dyspepsia/aerophagia/abdominal migraine
- •Growth failure,
- •Alarm signs of organic conditions.
结局指标
主要结局
Prevention of Abdominal pain
时间窗: 18 months
Primary outcome will be the incidence in IBS in children receiving LGG as compared to those receiving placebo. We have chosen pain as the primary outcome measure, in line with the proposed points-toconsider for IBS trials (Corazziari E. Consensus report: Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome. Aliment Pharmcol Ther 2003;18:569). IBS or chronic abdominal pain will be diagnosed and categorised according to ROME III criteria (Rasquin A, Di Lorenzo C, Forbes D, et al. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006;130).
次要结局
- Incidence of IBS(6 months)
- Children's health(24 months)
- Intestinal microbiota(24 months)
研究者
Ruggiero Francavilla
MD, PhD
University of Bari