Nutritional Drink in Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Safety will be measured by the NIH PROMISE scale at baseline
研究概览
简要总结
Gastroparesis is a chronic, morbid and costly neuromuscular disorder of the stomach characterized by delayed gastric emptying in the absence of gross structural abnormalities. The periprandial symptoms associated with this disease can preclude adequate oral intake and often lead to weight loss and nutritional deficiencies 1. These manifestations are largely due to impaired gastric accommodation of meals and delayed transfer of food boluses from the stomach into the duodenum2. Consequently, the investigators hypothesize that dietary supplementation with a low volume, hypercaloric nutritional drink can help prevent malnutrition, decrease symptom burden and improve health-related quality of life in this population. Due to the paucity of such a supplement, the investigators developed a novel nutritional drink designed to maximize tolerability in patients with gastroparesis . This nutritional drink was tested on healthy volunteers (phase I) and passed the palatability test. The investigators now aim to test the tolerability of this drink on gastroparesis patients.
详细描述
Primary objective:
To evaluate the safety and tolerability of the nutritional drink in gastroparesis patients.
Secondary objective:
To evaluate the efficacy of the nutritional drink in gastroparesis patients.
Study Procedures This study will be a pilot, open-label, trial in gastroparesis patients. A total of 20 patients will be recruited from the gastroenterology gastroparesis clinic. If the volunteer meets eligibility criteria, a co-investigator will contact the patient to schedule a study visit with a nutritionist and obtain a written consent. The contact and screening information of patients that are successfully recruited will be documented, placed in the participant's study folder and stored in a locked cabinet in the research unit. Any information documented during the screening process for patients who do not meet basic eligibility criteria or do not wish to participate will be immediately destroyed.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastroparesis confirmed with symptoms and a gastric emptying study.
- •Inability to maintain adequate caloric intake by standard dietary measures for gastroparesis due to gastrointestinal symptoms
排除标准
- •Recent diagnosis of disorder other than gastroparesis that could affect food intake
- •Oropharyngeal dysphagia or other condition with risk for aspiration from oral ingestion.
- •Allergic reactions to any of the ingredients of the nutritional drink
- •Current pregnancy. Pregnancy status will be determined by questioning the potential subject.
- •Patient with gastrostomy/jejunostomy tube feeds or on total parenteral nutrition
- •Currently taking any anti-coagulant
结局指标
主要结局
Safety will be measured by the NIH PROMISE scale at baseline
时间窗: Baseline
This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.
Safety will be measured by the NIH PROMISE scale at 6 weeks
时间窗: 6 weeks post-intervention
This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.
Tolerability will be measured by the Palatability Questionnaire at 2 days
时间窗: 2 days post-intervention
Patients will be given enough supply of the nutrition drink for 4 weeks and asked to consume 200 ml of the drink three times daily. A follow-up call will be scheduled on day 2 of the study to make sure patients are tolerating the drink. Tolerability will be measured by the Palatability Questionnaire which rates six items on a scale of 1 to 5 (1= strongly disagree and 5= strongly agree. The six items are: * The formula/supplement tasted very good. * The formula/supplement tasted very bad. * I had no problems drinking the supplement. * Drinking the supplement made me feel ill. * I could drink more of this supplement anytime * I would never drink more of this supplement again
Tolerability will be measured by the Palatability Questionnaire at 7 days
时间窗: 7 days post-intervention
Patients will be given enough supply of the nutrition drink for 4 weeks and asked to consume 200 ml of the drink three times daily. A follow-up call will be scheduled on day 7 of the study to make sure patients are tolerating the drink. Tolerability will be measured by the Palatability Questionnaire which rates six items on a scale of 1 to 5 (1= strongly disagree and 5= strongly agree. The six items are: * The formula/supplement tasted very good. * The formula/supplement tasted very bad. * I had no problems drinking the supplement. * Drinking the supplement made me feel ill. * I could drink more of this supplement anytime * I would never drink more of this supplement again
Tolerability will be measured by the Palatability Questionnaire at 4 weeks
时间窗: 4 weeks post-intervention
Patients will be given enough supply of the nutrition drink for 4 weeks and asked to consume 200 ml of the drink three times daily. A follow-up call will be scheduled at 4 weeks to make sure patients are tolerating the drink. Tolerability will be measured by the Palatability Questionnaire which rates six items on a scale of 1 to 5 (1= strongly disagree and 5= strongly agree. The six items are: * The formula/supplement tasted very good. * The formula/supplement tasted very bad. * I had no problems drinking the supplement. * Drinking the supplement made me feel ill. * I could drink more of this supplement anytime * I would never drink more of this supplement again
Safety will be measured by the NIH PROMISE scale at 4 weeks
时间窗: 4 weeks post-intervention
This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.
Safety will be measured by the NIH PROMISE scale at 2 weeks
时间窗: 2 weeks post-intervention
This will be measured by the NIH PROMISE scale. This is a 10 point scale (0=none and 10= most severe) that rates the following symptoms: * Pain, especially in the abdomen, chest or back * Abdominal distension (bloating, sensation of excess gas) * Difficulty eating, sensation of food being stuck in the stomach. * Difficulty with bowel movements (constipation or straining) * Nausea and/or vomiting * Thirst * Weakness, lack of energy, fatigue, difficulty moving.
次要结局
- Improvement in gastroparesis symptoms(Baseline, 2, 4 and 6 weeks)