Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus plantarum 299v receivers | Experimental | Sanprobi IBS (Lactobacillus plantarum 299v) 2 capsules per day for 4 weeks. |
|
| Placebo receivers | Placebo Comparator | Sanprobi IBS placebo 2 capsules per day for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum 299v | Dietary Supplement | Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of fat mass | fat mass in percent (%) | at baseline and after 4th week |
| Changes of muscle mass | muscle mass in kilograms (kg) | at baseline and after 4th week |
| Changes of total body water | total body water in percent (%) | at baseline and after 4th week |
| Changes of body mass index | body mass index in kg/m^2 | at baseline and after 4th week |
| Changes of the albumin concentration | albumin concentration g/L | at baseline and after 4th week |
| Changes of total protein concentration | total protein concentration g/L | at baseline and after 4th week |
| Changes of total lymphocyte count | number of total lymphocyte count/mm^3 | at baseline and after 4th week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of enteral nutrition tolerance | The enteral nutrition tolerance will be assessed with authors own questionnaire referring to number of stools, frequency of vomiting and flatulence. | it will be filled every day by patients per 4 weeks treatment period |
| Change of patients' quality of life ( BREF - WHOQOL - Bref The World Health Organization Quality of Life) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutritional Counselling Centre Copernicus in Gdansk | Gdansk | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32917221 | Derived | Kazmierczak-Siedlecka K, Folwarski M, Skonieczna-Zydecka K, Ruszkowski J, Makarewicz W. The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial. Nutr J. 2020 Sep 11;19(1):98. doi: 10.1186/s12937-020-00598-w. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Administration of placebo in cancer patients who receive home enteral nutrition. |
|
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. |
| at baseline and after 4th week |