Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Efficacy
研究概览
简要总结
The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.
详细描述
Most patients with functional gastrointestinal disorders complain of gas-related symptoms which can negatively affect quality of life, even in pediatric age.
Dietary and life-style changes, administration of simethicone, activated charcoal and probiotics may reduce intestinal gas but often results are unsatisfactory.
Literature shows that α-galactosidase is effective to reduce gas production and related symptoms in adults.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.
排除标准
- •suspected episodes of hypersensitivity or allergy;
- •chronic organic disorders (by clinical history, physical examination, laboratory tests);
- •use of drug affecting the GI motility during the previous 4 weeks;
- •inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.
结局指标
主要结局
Efficacy
时间窗: 5 weeks of observation
Global distress associated with gas-related symptoms (bloating, flatulance, abdominal distension and abdominal spasm): data collected by parents or patients on a daily diary chart, 3 time/daily by using a validated visual score scale (Faces Pain Scale-Revised).
次要结局
- Clinical tolerability(treatment: 2 weeks)
- Efficacy(5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks))
研究者
Giovanni Di Nardo
MD
Azienda Policlinico Umberto I