Delivered Dietary Intervention for Children With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Average daily abdominal pain frequency
研究概览
简要总结
The purpose of this study is to determine whether a specific diet may help children with irritable bowel syndrome.
详细描述
Many children experience stomach pain or discomfort at some point during their lives. Some children have belly discomfort frequently while others rarely have this problem. There have been very few studies to test treatments for recurrent stomach discomfort in children. Recently, studies in adults with recurrent stomach discomfort suggest that diet changes may help. Currently, we do not know if these same diets will work in children with the same problem.
In this study, two different diets will be provided (delivered) for two days with at least 5 days in between each provided diet. The child's symptoms will be recorded over the two days of each diet. Children will be asked to capture samples of their breath during the last day of the each two day delivered diet. Stool samples will also be collected.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must include all of the following:
- •Children between the ages of 7-17 years;
- •Meet the criteria for IBS based on the Questionnaire on Pediatric Gastrointestinal Symptoms Rome III Version, including pain/discomfort a minimum of twice per week;
- •Negative physician evaluation for an organic etiology of the pain within the past year
排除标准
- •Will include any of the following:
- •Diabetes or other disease process requiring specialized dietary management;
- •Malnutrition or obesity (BMI >95%);
- •Inability to eat by mouth;
- •Antibiotic or medicinal probiotic usage within the past 3 months (excluding yogurt);
- •Neuromodulator (e.g. amitriptyline) usage within the past 3 months
- •Start of, or change in gastrointestinal medication (e.g. laxative) dose that may cause or ameliorate abdominal symptoms within the past month
结局指标
主要结局
Average daily abdominal pain frequency
时间窗: 9 days (2 dietary intervention periods)
Comparisons of abdominal pain frequency (number of abdominal pain episodes per day) will be made between each two day dietary period spanning a 9 days.
次要结局
- Abdominal pain severity(9 days (2 dietary intervention periods))
- Hydrogen gas production(9 days (2 dietary intervention periods))
研究者
Bruno Chumpitazi
Assistant Professor
Baylor College of Medicine