Study to Intervene With Nutrition for Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change from baseline in Gastroparesis Cardinal Symptom Index (GCSI) Symptoms Index (GCSI) score as measure of the effect of KF Peptide 1.5 nutritional formula.
研究概览
简要总结
The study is a self-controlled study in which we will assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula in patients with gastroparesis, relative to their pre-enrollment nutritional diet regimen.
详细描述
The study is a prospective self-controlled study in which we will assess the nutritional effects of Kate Farm Peptide 1.5 nutritional formula in patients with gastroparesis, relative to their pre-enrollment diet regimen.
The duration of the study will be 12 weeks. We plan to recruit a total of 30 patients. Patients will undergo a baseline measurement of their height, weight, symptom burden, resting energy expenditure, inflammation, and microbiome. After study initiation, patient will undergo repeat testing at 1- and 3-months post-enrollment. Including the screening and baseline visits, there will be a total of 4 visits required to complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in Gastroparesis Cardinal Symptom Index (GCSI) Symptoms Index (GCSI) score as measure of the effect of KF Peptide 1.5 nutritional formula.
时间窗: Screening, Baseline and through end of study (12 weeks)
9-item measure of severity of gastroparesis symptoms on a scale of 0-5 (none to worst) Higher values represent a worse outcome.
次要结局
- Inflammatory markers(Baseline through end of study (12 weeks))
- Weight(Baseline through end of study (12 weeks))
- Change in Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Disorders-Symptom Severity Index (PAGI-SYM) score as measure of the effect of KF Peptide 1.5 nutritional formula.(Baseline through end of study (12 weeks))
- Total energy requirement(At Baseline and end of study (12 weeks))
研究者
Linda Nguyen
Clinical Associate Professor
Stanford University