Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acceptance, Tolerance and Nutritional Status
研究概览
简要总结
The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product.
The main objectives of this project are:
- Comparing the tolerance of both preparations.
- Comparing the evolution of nutritional status in both groups.
- Comparing the evolution of inflammatory parameters in both groups
详细描述
Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 with Mild Acute Pancreatitis.
排除标准
- •Patients with Several Acute Pancreatitis
- •Patients with life expectancy less than 48 hours.
- •Renal (creatinin > 2,5 mg/dl) or kidney failure (GOT/GPT>2 from laboratory normal value)
- •Patients with diabetes mellitus prior to acute pancreatitis.
- •To take part in another study.
- •Pregnant patients
- •Informed consent absence.
结局指标
主要结局
Acceptance, Tolerance and Nutritional Status
时间窗: 1 year
* To compare the acceptance and tolerance of both products. * To compare the nutritional status in both arms.
次要结局
- Inflammatory parameters evolution and EN complications(1 year)