The Use of Lactobacillus gg in Functional Abdominal Pain in Children: a Double-blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
研究概览
简要总结
Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Even though most of the studies demonstrate efficacy, other studies do not support these observations. Few studies addresses the efficacy of probiotics in children with IBS. The goal of the present study was to determine whether oral administration of the probiotic Lactobacillus GG under randomized, double-blind, placebo-controlled conditions would improve symptoms of children with abdominal pain.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
- •IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:
- •relieved with defecation
- •onset associated with a change in stool frequency
- •onset associated with a change in the form (appearance) of the stool.
- •FAP was diagnosed in presence of symptoms of
- •Continuous (nearly continuous) abdominal pain
- •No or only occasional relation of pain with physiological events (e.g. eating, menses)
- •Some loss of daily functioning
- •The pain is not feigned (e.g. malingering)
- •The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.
排除标准
- •Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
- •Treatment with antibiotics/probiotics in the last 2 months
- •A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
- •Growth failure
- •Gastroparesis
- •Gastrointestinal obstructions/stricture
- •Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
- •Previous abdominal surgery.
结局指标
主要结局
The primary outcome measure was defined as reduction of pain (both number of episodes and intensity) at the end of the intervention.
时间窗: 12 weeks and 20 weeks
次要结局
未报告次要终点