NCT02117180Unknown1 期
Evaluation of the Nutritional Adequacy of a Diet Low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP's) in Children With Functional Gastrointestinal Disorders.
Dr Anne Payne2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年2月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Energy and nutrient intake
研究概览
简要总结
This pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. A larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 10-16 years
- •Informed consent and assent obtained
- •Patients with diagnosed FGID according to Rome III criteria: i.e. category H2b (irritable bowel syndrome) and H2d (childhood functional abdominal pain)
排除标准
- •Patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease)
- •Patients with food allergies
- •Patients with a weight for age below -2 Standard Deviations (SD) (below 0.4th centile) on the UK WHO growth charts.
- •Patients with known micronutrient deficiencies determined by blood levels prior to study
- •Patients without informed consent and assent obtained
结局指标
主要结局
Energy and nutrient intake
时间窗: Baseline, 6 weeks
Energy and nutrient intake will be assessed using a 4-day estimated food diary at baseline and 6-weeks after dietary intervention. Comparison will be made between baseline and 6-week data and with United Kingdom (UK) Reference Nutrient Intakes.
次要结局
- Anthropometry: weight and mid-arm circumference(Baseline, 6 weeks)
- Practicality of the FODMAP diet; impact of diet on Functional Gastro-Intestinal .Disorders (FGID) symptoms and stools(Baseline, 6 weeks)
研究者
Dr Anne Payne
Associate Professor/Academic Lead for Nutrition & Dietetics
University of Plymouth
研究点 (2)
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