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
- 1
- 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
- •Identify inclusion criteria.
- •Male or female gender
- •Ages 18 to 65
- •Established diagnosis of gastroparesis confirmed by gastric emptying study within the last 5 years.
- •No changes to gastroparesis medications in the 3 months prior to recruitment.
- •Patients with hysterectomy, appendectomy, cholecystectomy and fundoplication are ok to participate.
- •Able to give informed consent.
- •Patient willing to supplement diet with Kate Farms
- •Ability to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Are nursing or pregnant.
- •Diagnosis of mechanical small bowel obstruction within 3 months prior to recruitment
- •Patients with a history of gastric surgery, including gastrectomy, small bowel resection or bariatric surgery
- •The use of narcotic medications in the month prior to study enrollment or during the study period
- •Diagnosis of short gut syndrome
- •Allergic to any ingredients in the Kate Farms formula
- •Untreated small intestinal bacterial overgrowth
研究组 & 干预措施
Assess Nutritional Effects of Nutritional Formula
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 formula regimen.
干预措施: Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula (Dietary Supplement)
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
- Weight(Baseline through end of study (12 weeks))
- Inflammatory markers(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