scholarly journals The use of Lactobacillus plantarum 299v (DSM 9843) in patients with cancers receiving home enteral nutrition – study protocol for a randomized, double-blind, and placebo-controlled trial

2020 ◽  
Author(s):  
Kaźmierczak-Siedlecka Karolina ◽  
Marcin Folwarski ◽  
Karolina Skonieczna-Żydecka ◽  
Jakub Ruszkowski ◽  
Wojciech Makarewicz
Keyword(s):  
Quality Of Life ◽  
Enteral Nutrition ◽  
Nutritional Status ◽  
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 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

scholarly journals 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

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

scholarly journals 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

2020 ◽  
Vol 19 (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.

scholarly journals 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

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

scholarly journals 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

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)

The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial

2018 ◽  
Vol 26 (9) ◽  
pp. 3029-3038 ◽  
Author(s):  
Jenny G. Turcott ◽  
María del Rocío Guillen Núñez ◽  
Diana Flores-Estrada ◽  
Luis F. Oñate-Ocaña ◽  
Zyanya Lucia Zatarain-Barrón ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Clinical Trial ◽  
Nutritional Status ◽  
Cancer Patients ◽  
Double Blind ◽  
Lung Cancer Patients ◽  
Double Blind Clinical Trial

scholarly journals Integrative Treatment of Lung Cancer Patients: Observational Study of 57 Cases

2021 ◽  
Author(s):  
Lorenzo Anelli ◽  
Alessia Di Nardo ◽  
Massimo Bonucci
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Nutritional Status ◽  
Cancer Patients ◽  
Immune Status ◽  
Conventional Medicine ◽  
Integrative Therapy ◽  
Lung Cancer Patients ◽  
Retrospective Clinical Study

Abstract Introduction A retrospective clinical study was performed to identify the characteristics of patients with lung cancer treated with integrative cancer treatment in addition to conventional medicine. Materials and Methods We reviewed medical records for lung cancer patients who visited a single integrative setting in Rome, Italy. A total of 57 patients were included, and the majority had advanced-stage cancer. All of them underwent integrative therapy with nutrition and phytotherapy indications. The diet was designed to reduce most of possible factors promoting cancer proliferation, inflammation, and obesity. Foods with anti-inflammatory, prebiotic, antioxidant, and anticancer properties had been chosen. Herbal supplements with known effects on lung cancer were prescribed. In particular, astragal, apigenine, fucosterol, polydatin, epigallocatechin gallate, cannabis, curcumin, and inositol were used. Furthermore, medical mushrooms and other substances were used to improve the immune system and to reduce chemotherapy side effects. Five key parameters have been evaluated for 2 years starting at the first surgery: nutritional status, immune status, discontinuation of therapy, quality of life, and prognosis of the disease. Results A relevant improvement in parameters relative to nutritional status, immune status, and quality of life has been observed after integrative therapy compared with the same parameters at the first medical visit before starting such approach. Conclusion The results suggest that integrative therapy may have benefits in patients with lung cancer. Even though there are limitations, the study suggests that integrative therapy could improve nutritional status and quality of life, with possible positive effect on overall survival.

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