The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition
- Conditions
- Cancer
- Interventions
- Dietary Supplement: Lactobacillus plantarum 299vDietary Supplement: Placebo
- Registration Number
- NCT03940768
- Lead Sponsor
- Medical University of Gdansk
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- age <18 yr.,
- patients requiring home parenteral nutrition,
- patients who are not being able to attend the visit in the study centre.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo receivers Placebo Sanprobi IBS placebo 2 capsules per day for 4 weeks. Placebo receivers Lactobacillus plantarum 299v Sanprobi IBS placebo 2 capsules per day for 4 weeks. Lactobacillus plantarum 299v receivers Lactobacillus plantarum 299v Sanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks. Lactobacillus plantarum 299v receivers Placebo Sanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks.
- Primary Outcome Measures
Name Time Method Changes of the albumin concentration at baseline and after 4th week albumin concentration g/L
Changes of fat mass at baseline and after 4th week fat mass in percent (%)
Changes of total body water at baseline and after 4th week total body water in percent (%)
Changes of body mass index at baseline and after 4th week body mass index in kg/m\^2
Changes of muscle mass at baseline and after 4th week muscle mass in kilograms (kg)
Changes of total protein concentration at baseline and after 4th week total protein concentration g/L
Changes of total lymphocyte count at baseline and after 4th week number of total lymphocyte count/mm\^3
- Secondary Outcome Measures
Name Time Method Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life) at baseline and after 4th week Questionare containing questions divided in 4 domains (regarding environment, psychological, somatic, social factors). Each question gets points in scale 1-5, where 1 being the worst score. Within each domain poins are summed up.
Change of enteral nutrition tolerance it will be filled every day by patients per 4 weeks treatment period The enteral nutrition tolerance will be assessed with authors own questionnaire referring to number of stools, frequency of vomiting and flatulence.
Trial Locations
- Locations (1)
Nutritional Counselling Centre Copernicus in Gdansk
🇵🇱Gdańsk, Poland