The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Changes of the albumin concentration
研究概览
简要总结
The aim of the study is to assess the impact of Lactobacillus plantarum 299v on nutritional status, tolerance of enteral diet and the quality of life. Administration of this probiotic may potentially improve nutritional status and tolerance of enteral diet. It also may provide positive effect on quality of life.
详细描述
Study group consists of patients with cancer who are qualified for home enteral nutrition in Nutritional Counselling Center Copernicus in Gdansk. The control group will receive home enteral nutrition and placebo. The experimental group will receive home enteral nutrition and Lactobacillus plantarum 299v. The study is prospective and double-blind. The parameters for evaluation of nutritional status are: BMI, body mass analysis, level of total protein and albumin in blood serum, total lymphocyte count, NRS 2002 method. Assessment of the quality of life and tolerance of enteral diet will be done by questionaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •age ≥18 yr.,
- •the presence of cancer, artificial access to the alimentary tract (naso-gastric tube, gastrostomy, percutaneous endoscopic gastrostomy, jejunostomy, microjejunostomy),
- •qualification for home enteral nutrition,
- •written consent to take part in the study
排除标准
- •age <18 yr.,
- •patients requiring home parenteral nutrition,
- •patients who are not being able to attend the visit in the study centre.
结局指标
主要结局
Changes of the albumin concentration
时间窗: at baseline and after 4th week
albumin concentration g/L
Changes of fat mass
时间窗: at baseline and after 4th week
fat mass in percent (%)
Changes of total body water
时间窗: at baseline and after 4th week
total body water in percent (%)
Changes of body mass index
时间窗: at baseline and after 4th week
body mass index in kg/m\^2
Changes of muscle mass
时间窗: at baseline and after 4th week
muscle mass in kilograms (kg)
Changes of total protein concentration
时间窗: at baseline and after 4th week
total protein concentration g/L
Changes of total lymphocyte count
时间窗: at baseline and after 4th week
number of total lymphocyte count/mm\^3
次要结局
- Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life)(at baseline and after 4th week)
- Change of enteral nutrition tolerance(it will be filled every day by patients per 4 weeks treatment period)
研究者
Karolina Kaźmierczak-Siedlecka
Karolina Kaźmierczak-Siedlecka (nutritionist, PhD student - Department of Surgical Oncology)
Medical University of Gdansk