Randomised Controlled Trial With Two Parallel Arms Testing the Effect of L. Reuteri on Bowel Movements in Children Aged 6 Months to 4 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Change in number of spontaneous bowel movements
研究概览
简要总结
A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.
详细描述
Functional constipation in infants up to 4 years of age is defined according to Rome III criteria (Hyman 2006). The diagnose must include 1 month of at least two of the following criteria: two or fewer defecations per week; at least 1 episode per week of incontinence after the acquisition of toilet skills; history of excessive stool retention; history of painful or hard bowel movements; presence of a large faecal mass in the rectum; history of large-diameter stools that may obstruct the toilet.
Accompanying symptoms may include irritability, decreased appetite and/or early satiety. The accompanying symptoms disappear immediately following passage of a large stool.
There is a growing interest for the use of probiotics in functional constipation as research suggests that probiotics could provide beneficial support in the traditional treatment arsenal although the mechanisms of actions are not completely understood.
Wu et al have demonstrated that Lactobacillus reuteri DSM 17938 may have a region-specific intestinal effect on gut motility and therefore could be beneficial in treatment of constipation
Lactobacillus reuteri DSM 17938 has shown significant favourable effects in adults (Ojetti 2014) and young children as described above (Coccorullo 2010, Olgac 2013). These studies require confirmation however. The present clinical study has been designed to strengthen the current available data that L. reuteri DSM 17938 has beneficial effects in infants and young children with functional constipation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6 months up to 4 years
- •Suffering from functional constipation, as defined by modified Rome III criteria for children aged 4 years or less (Hyman 2006)
- •Parent(s) willingness to postpone major changes in the infant feeding mode
- •Parent(s) willingness and ability to fill in diary and questionnaires
- •Written informed consent from parents
- •Stated availability throughout the study period
排除标准
- •Chronic illness or major medical problem
- •Gastrointestinal disease (including organic cause of constipation and dyschezia or history of severe fecalome)
- •Intractable constipation (not responding to conventional treatment for more than 3 months)
- •Gastrointestinal surgery (in the year before enrolment)
- •Food allergy, lactose or gluten intolerance, as declared by parents
- •Use of L. reuteri two weeks before randomisation and throughout the intervention period. If fed with infant formula, it cannot contain L. reuteri.
- •Use of antibiotics two weeks before randomisation and throughout the intervention period, both infant/child and lactating mother
- •If breastfeeding, use of L reuteri by the mother 2 weeks prior to enrolment
- •Conventional treatment for constipation within 2 weeks before enrolment
- •Medication that influences gastrointestinal motility
- •Mental or behavioral disorders as judged by the investigator
研究组 & 干预措施
L.reuteri
probiotics: L.reuteri produced by Biogaia 5 drops per day: 10exp(8) colony forming unit will be delivered
干预措施: L.reuteri (Dietary Supplement)
Placebo
Same formulation as probiotics, without active substance. 5 drops per day will be delivered
干预措施: Placebo (Drug)
结局指标
主要结局
Change in number of spontaneous bowel movements
时间窗: Week 4
Change in number of spontaneous bowel movements at week 4 compared to baseline evaluated by a bowel habit questionnaire (BQH)
次要结局
- rescue medication(week 4)
- fecal retention(week 4)
- Pain during defecation(week 8)
- Score of QOL(week 8)
- weekly number of spontaneous bowel movements(week 8)
研究者
Camille JUNG
Head of the clinical research department
Centre Hospitalier Intercommunal Creteil