Efficacy of Lactobacillus Reuteri Protectis on Functional Abdominal Pain (FAP) in Children 8-14 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- BioGaia AB
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Primary endpoint
研究概览
简要总结
The present clinical trial will examine the use of L. reuteri Protectis in children with functional abdominal pain. The aim of the study is to evaluate the use of L. reuteri Protectis on pain (severity and frequency) in children of 8-14 years old and with diagnosis of functional abdominal pain (FAP).
详细描述
Subject will be asked to consume a tablet every day for 4 weeks. Supplementation will be stopped after 4 weeks, and the subjects will be followed up for an additional 4 weeks. The subjects will complete a diary to record frequency and intensity of pain, use of medication, deviation from the usual diet, physical activities, and absence from school and other activities. Gastrointestinal symptoms are assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FAP (Functional Abdominal Pain) according to Rome III criteria for
- •Child/Adolescent (Rasquin, 2006);
- •1 or more abdominal pain episodes per week over the past 8 weeks;
- •Informed consent by study participant and at least one parent / legal guardian;
- •Age 8-14 years;
- •Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
- •Ability to understand and comply with the requirements of the trial;
- •Stated availability throughout the study period.
排除标准
- •Chronic illness;
- •Surgery of Gastrointestinal tract;
- •Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
- •Weight loss of 5% or more in body weight over the preceding 3 months;
- •Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
- •Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;
- •Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.
- •Participation in other clinical trials in the past 3 months;
- •Subjects with anemia;
- •Subjects with special dietary needs
结局指标
主要结局
Primary endpoint
时间窗: 4 weeks
Pain frequency measured by a subject diary, in the L. reuteri Protectis group and the placebo group, expressed as area under the pain-frequency curve and comparing L. reuteri Protectis vs. placebo over the 4-week supplementation period.
次要结局
- Secondary endpoint(56 days)