The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition

Abstract Background Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered a safe procedure, however, may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v may be used as a supportive therapy in patients suffering from irritable bowel syndrome and Clostridium difficile infection. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on nutritional status of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of tolerance of enteral formula and patients’ quality of life. Methods Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), tolerance of enteral nutrition as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment. Discussion It is expected that the Lactobacillus plantarum 299v will provide beneficial effects, such as maintenance or improvement of nutritional status, enteral formula tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768

Download Full-text

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

10.21203/rs.2.23667/v3 ◽

2020 ◽

Author(s):

Kaźmierczak-Siedlecka Karolina ◽

Marcin Folwarski ◽

Karolina Skonieczna-Żydecka ◽

Jakub Ruszkowski ◽

Wojciech Makarewicz

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Enteral Nutrition ◽

Cancer Patients ◽

Lactobacillus Plantarum ◽

Probiotic Strain ◽

Double Blind ◽

Home Enteral Nutrition ◽

Enteral Formula

Abstract Background Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on nutritional status of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of enteral nutrition tolerance and patients’ quality of life. Methods Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment. Discussion The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients’ quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768

Download Full-text

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

Nutrition Journal ◽

10.1186/s12937-020-00598-w ◽

2020 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Karolina Kaźmierczak-Siedlecka ◽

Marcin Folwarski ◽

Karolina Skonieczna-Żydecka ◽

Jakub Ruszkowski ◽

Wojciech Makarewicz

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Enteral Nutrition ◽

Cancer Patients ◽

Lactobacillus Plantarum ◽

Probiotic Strain ◽

Double Blind ◽

Home Enteral Nutrition ◽

Enteral Formula

Abstract Background Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on prevention of weight loss of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of nutritional status, enteral nutrition tolerance, and patients’ quality of life. Methods Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment. Discussion The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients’ quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768.

Download Full-text

Effects of 4 weeks of Lactobacillus plantarum 299v supplementation on nutritional status, enteral nutrition tolerance, and quality of life in cancer patients receiving home enteral nutrition – a double-blind, randomized, and placebo-controlled trial

10.21203/rs.3.rs-22190/v1 ◽

2020 ◽

Author(s):

Kaźmierczak-Siedlecka Karolina ◽

Marcin Folwarski ◽

Jakub Ruszkowski ◽

Karolina Skonieczna-Żydecka ◽

Waldemar Szafrański ◽

...

Keyword(s):

Quality Of Life ◽

Enteral Nutrition ◽

Nutritional Status ◽

Cancer Patients ◽

Lactobacillus Plantarum ◽

Gastrointestinal Symptoms ◽

Controlled Study ◽

Double Blind ◽

Home Enteral Nutrition

Abstract BackgroundSeveral human trials have confirmed that Lactobacillus plantarum 299v (Lp299v) relief the gastrointestinal symptoms observed in patients with irritable bowel syndrome, such as nausea, vomiting, and diarrhoea. These symptoms are similar to those associated with home enteral nutrition and they affect nutritional status as well as patients’ quality of life.MethodsThe current double-blind, randomized, and placebo-controlled study included 35 cancer patients receiving home enteral nutrition. There were 2 groups of participants consuming either 2 × 1010 CFU of Lp299v (n = 21) or placebo (n = 14) for 4 weeks. The aims of this study were to determine the effect of Lp299v on nutritional status, enteral formula tolerance, and quality of life in cancer patients.ResultsAn increase in serum albumin concentration was significantly higher in the Lp299v group than in the placebo group at the endpoint (p = 0.032). Moreover, the changes in the frequency of vomiting and flatulence were significantly reduced at week 4 compared to baseline in the Lp299v group (p = 0.0117). The improvement of quality of life was observed in both groups; however, with no statistically significant differences between the analysed groups (p > 0.05).ConclusionsWe have demonstrated that administration of Lp299v in cancer patients receiving home enteral nutrition may improve laboratory parameters, predominantly the concentration of albumin, however, overall it does not have an impact on nutritional status. Lp299v may reduce the gastrointestinal symptoms related to enteral nutrition; notwithstanding, the improvement of quality of life may be the result of enteral nutrition rather than the effect of administration of Lp299v.Trial registration ClinicalTrials.gov (identifier: NCT03940768)

Download Full-text

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

10.21203/rs.2.23667/v2 ◽

2020 ◽

Author(s):

Kaźmierczak-Siedlecka Karolina ◽

Marcin Folwarski ◽

Karolina Skonieczna-Żydecka ◽

Jakub Ruszkowski ◽

Wojciech Makarewicz

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Enteral Nutrition ◽

Cancer Patients ◽

Lactobacillus Plantarum ◽

Probiotic Strain ◽

Double Blind ◽

Home Enteral Nutrition ◽

Enteral Formula

Abstract Background Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on nutritional status of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of enteral nutrition tolerance and patients’ quality of life. Methods Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment. Discussion The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients’ quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition. Trial registration ClinicalTrials.gov Identifier: NCT03940768

Download Full-text

Home enteral nutrition via gastrostomy in advanced cancer patients

Clinical Nutrition ◽

10.1016/0261-5614(89)90195-7 ◽

1989 ◽

Vol 8 ◽

pp. 68

Keyword(s):

Enteral Nutrition ◽

Cancer Patients ◽

Advanced Cancer ◽

Advanced Cancer Patients ◽

Home Enteral Nutrition

Download Full-text

Home Enteral Nutrition in Adults—Nationwide Multicenter Survey

Nutrients ◽

10.3390/nu12072087 ◽

2020 ◽

Vol 12 (7) ◽

pp. 2087

Author(s):

Marcin Folwarski ◽

Stanisław Kłęk ◽

Agata Zoubek-Wójcik ◽

Waldemar Szafrański ◽

Lidia Bartoszewska ◽

...

Keyword(s):

Enteral Nutrition ◽

Cancer Patients ◽

Observation Time ◽

Nutritional Interventions ◽

Home Enteral Nutrition ◽

Diet Formulation ◽

Multicenter Survey ◽

Neurological Patients ◽

Nation Wide Survey ◽

Surgical Gastrostomy

Home enteral nutrition (HEN) is an important part of the health care system, with a growing population of patients around the world. The aim of our study was to analyze one of the largest cohorts of HEN patients to provide the most recent data available in European literature. A multicenter, nation-wide survey in the period of 1 January 2018–1 January 2019 was performed in Poland. Data concerning adult patients on HEN in 2018 during 1 year of observation time were analyzed: demographic characteristics, primary disease, technique of enteral feeding, diet formulation and amount of energy provided. A total of 4586 HEN patients (F: 46.7%, M: 53.3%) were included in the study. The primary diseases were: 54.5% neurological (17.4%—neurovascular, 13.7%—neurodegenerative), 33.9% cancer (20.2%—head and neck, 11.7%—gastrointestinal cancer), 2.5%—gastroenterology, 1.5%—inherited diseases. Of new registrations in 2018—cancer patients 46.3%, neurological patients 45.1%. The median age overall was: 64 yr., BMI-20.2 kg/m2, NRS 2002 score—4.28. A total of 65% of patients were treated with PEG, 11.6% with surgical gastrostomy, 14.3% with naso-gastric tube and 7% with jejunostomy. Boluses were the most common method of feeding (74.4%). Gravity flow was used in 17.6% and peristaltic pump was used in 8% patients. The median energy provision was 1278 kcal/day and 24 kcal/kg/day. The most commonly used diets were: isocaloric (28.1%), protein-enriched isocaloric (20%) and protein-enriched hypercaloric (12%). The median overall duration of HEN was 354 days, 615 days for neurological and 209 days for cancer patients. A number of new registrations of cancer patients was significant and long duration of HEN in this group is encouraging. A developing spectrum of enteral formulas available enables more specified nutritional interventions.

Download Full-text