The Study of Nutrition of Children and Adolescents With GERD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- total carbohydrate consumption
研究概览
简要总结
This trial is to study the aspects of nutrition in children and adolescents with GERD compared to the sex and age-matched control group
详细描述
The aim of the study is to assess the differences in nutrition of pediatric patients with GERD compared to the control group. The secondary aim is to study possible associations of the data on nutritional habits revealed with the use of food frequency questionnaire (FFQ) and the data of 24-hours oesophageal pH-impedance examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willingness to participate (written informed consent and consent from parents or legal representative according to the local law);
- •Age 6 to 17 years old inclusive,
- •Possibility to assess symptoms, data of the medical history and receive answers to the questions about usual diet.
排除标准
- •history of abdominal surgery;
- •presence of varicose veins of the stomach and/or the oesophagus either in medical history or found during the study;
- •inability to tolerate at least one of the invasive procedures or lacking data of the other instrumental examinations required by protocol;
- •general condition of the patient making impossible to perform all the examinations or when performing the procedures is not safe and reasonable based on the opinion of the investigator that it may exacerbate the disease flow or put the patient at risk;
- •intake of medications which may influence the clinical and instrumental data, including, but not limited to: non-steroid anti-inflammatory agents, glucocorticosteroids (except for skin products, if they were used for 2 weeks or less at the time of inclusion into the study), medications affecting adrenergic, acetylcholine receptors, antidepressants, tranquillizers, sedatives, those with known local irritant effect on the gastrointestinal tract mucosa; the use of proton pump inhibitors and H2 receptors blockers are not allowed during the study, a wash-out period for at least 2 weeks is necessary before the enrolment.
结局指标
主要结局
total carbohydrate consumption
时间窗: An average of 1 year
value of mean daily consumption of carbohydrates, by food frequency questionnaire, G/day
total fat consumption
时间窗: An average of 1 year
value of mean daily consumption of fats by food frequency questionnaire, G/day
total protein consumption
时间窗: An average of 1 year
value of mean daily consumption of protein by food frequency questionnaire, G/day
Dietary fibre consumption
时间窗: An average of 1 year
value of mean daily consumption of dietary fibre, by food frequency questionnaire, G/day
Energy value of the ration
时间窗: An average of 1 year
value of mean daily consumption of the energy by food frequency questionnaire, kcal/day
次要结局
- Number of weak-acid gastroesophageal refluxes(24-hours)
- Total number of gastroesophageal refluxes(24-hours)
- Number of acid gastroesophageal refluxes(24-hours)
- Acid exposure time(24-hours)
- Number of high gastroesophageal refluxes(24-hours)
研究者
Sergey Morozov
Leading researcher
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology