Randomized Comparison of Elemental Diets and Semi-solid Diets on Gastric Excretion and Gastroesophageal Regurgitation in Bedridden Gastrostomy-fed Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Gastroesophageal regurgitation
研究概览
简要总结
Study 1: A randomized, crossover trial using elemental or semi-solid diets containing contrast medium as a tracer given to bedridden PEG patients. The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.
Study 2: A randomized, crossover trial using elemental or semi-solid diets containing 13C sodium acetate as a tracer given to bedridden PEG patients. 13C breath tests are performed to estimate gastric emptying.
详细描述
Study 1: A mix of elemental or semi-solid diet (300 kcal/300 mL ) and contrast medium (5ml) is administered using PEG, respectively. Using a plain CT, the distribution of the administered diet is assessed at the distal esophagus, proximal and distal stomach before and 1 hour after the administration. The volume of the residual diet at the distal esophagus, proximal and distal stomach is compared between an elemental and semi-solid diet.
Study 2: Either the elemental diet or semi-solid diet (200 kcal/200 mL) is labeled with 100 mg [13C]sodium acetate (Cambridge Isotope Laboratories Inc, Cambridge, MA) and is administered in the first 15 min of the examination at the same speed using the PEG.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bedridden PEG patients are admitted for fever which is the most common reason for admission of PEG patients to our hospital.
排除标准
- •Regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.
研究组 & 干预措施
Elemental diet
Study 1: Elemental diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG.
Study 2: Elemental diet (200 kcal/200 mL) labeled with 100 mg [13C]sodium acetate is administered within 15 min using the PEG.
干预措施: Elmental diet (Drug)
Semi-solid diet
Study 1: Semi-solid diet (300 kcal/300 ml) containing a contrast medium (5 ml) is administered within 15 min using the PEG.
Study 2: Semi-solid diet (200 kcal/200 mL) labeled with 100 mg [13C]sodium acetate is administered within 15 min using the PEG.
干预措施: Semi-solid diet (Drug)
结局指标
主要结局
Gastroesophageal regurgitation
时间窗: A half year
The distribution of the administered diets is assessed at the distal esophagus, proximal and distal stomach using a plain CT before and 1 hour after the administration.
次要结局
- Gastric excretion(A half year)
研究者
Akira Horiuchi
Chief, Digestive Disease Center
Showa Inan General Hospital