Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- improvement of irritable bowel syndrome symproms
研究概览
简要总结
To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University
详细描述
Single blinded randomized two-arm intervention study in which 42 patients with irritable bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS were enrolled as a control group who were received general diet instructions and they followed the NICE guide lines for IBS management
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis
排除标准
- •Patients presenting with :
- •Abdominal pain or diarrhea that wakes the child from sleep
- •Delay in onset or progression of puberty.
- •Faltering growth.
- •Family history of inflammatory bowel disease, celiac disease.
- •History of significant weight loss .
- •Bleeding per rectum.
- •Persistence of severe vomiting or diarrhea
- •. Persistent joint pain.
- •Recurrent unexplained fever.
- •Unexplained pallor
研究组 & 干预措施
LOW FODMAP Diet group
42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis, and didn't have any of the following :o Abdominal pain or diarrhea that wakes the child from sleep
- Delay in onset or progression of puberty.
- Faltering growth.
- Family history of inflammatory bowel disease, celiac disease.
- History of significant weight loss .
- Bleeding per rectum.
- Persistence of severe vomiting or diarrhea
- . Persistent joint pain.
- Recurrent unexplained fever.
- Unexplained pallor they followed the low fodmapdiet for 6 weeks
干预措施: low fodmap diet (Other)
NICE guidelines group
42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis and didn't have one of the following : o Abdominal pain or diarrhea that wakes the child from sleep
- Delay in onset or progression of puberty.
- Faltering growth.
- Family history of inflammatory bowel disease, celiac disease.
- History of significant weight loss .
- Bleeding per rectum.
- Persistence of severe vomiting or diarrhea
- . Persistent joint pain.
- Recurrent unexplained fever.
- Unexplained pallor
they followed NICE guidelines for irritable bowel syndrome for 6 weeks
干预措施: NICE guidelines for IBS (Other)
结局指标
主要结局
improvement of irritable bowel syndrome symproms
时间窗: 6 weeks
Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score
次要结局
- improve patients quality of life(6 weeks)
研究者
Sarah Abdelrahman El Ezaby
Family Medicine assistant lecturer at Faculty of Medicine
Ain Shams University