Evaluation of the Effectiveness of the Low FODMAP Diet in the Treatment of Functional Abdominal Pain in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Assessment of abdominal pain severity
研究概览
简要总结
Diet components are important factors in pathogenesis of functional gastrointestinal disorders, especially in the irritable bowel syndrome. Fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) are a group of short chain, poorly absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms because of rapid fermentation in different segments of the gut. Low FODMAP diet is a novel treatment option with proven efficacy in reducing symptoms of functional gastrointestinal disorders in adults. Conversely, although functional abdominal pain is a common health problem in children, the efficacy of a low FODMAP diet remains understudied in this population.
The aim of this study was to compare the effects of two diets: a low FODMAP diet and a diet based on standard dietary advice of the National Institute for Health and Care Excellence (NICE), on abdominal symptoms in children with functional 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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •functional abdominal pain according to Rome III criteria
- •consent to participate in the study
- •positive decision of gastroenterologist concerning enrolment of the patient to the trial
排除标准
- •organic causes for gastrointestinal tract disorders,
- •occurrence of an abdominal migraine, IBS, food allergies or intolerances, other significant disorders, acute infection
- •antibiotic treatment within the last 8 weeks
研究组 & 干预措施
Low FODMAP diet group
four weeks of the low FODMAP diet based on Monash University low FODMAP diet App.
干预措施: The low FODMAP diet. (Other)
Control group
four weeks of the diet based on NICE guidelines and contained products with different FODMAP content
干预措施: The diet based on NICE guidelines. (Other)
结局指标
主要结局
Assessment of abdominal pain severity
时间窗: 6 weeks
Wong-Baker FACES Pain Rating Scale where 0 = no hurt and 10 = hurts worst was used for assessed severity of abdominal pain during the 6-week study period (2 weeks before and 4 weeks during the diet)
次要结局
- Assessment of abdominal pain and defecation frequency(6 weeks)
研究者
Katarzyna Boradyn
Principal Investigator
University of Warmia and Mazury