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)

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 Effect of Chocolate on Older Cancer Patients in Palliative Care: A Randomised Controlled Study

2021 ◽  
Author(s):  
Josiane C. Vettori ◽  
Luanda G. da-Silva ◽  
Karina Pfrimer ◽  
Jordão-Junior Alceu A ◽  
Paulo Louzada-Junior ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oxidative Stress ◽  
Palliative Care ◽  
Body Composition ◽  
Nutritional Status ◽  
Cancer Patients ◽  
Controlled Study ◽  
European Organization ◽  
Older Cancer Patients

Abstract Background Older advanced stage cancer patients, with changes in metabolic and nutritional status, represent an important demand for palliative care. The objective of the present study was to determine the effects of 4 weeks of chocolate consumption on the nutritional status, quality of life, body composition, oxidative stress and inflammaory activity of older cancer patients in palliative care. Methods Older cancer patients in palliative care with ambulatory monitoring were randomized to the following groups: control (CG, n = 15), intervention with 55% cocoa chocolate (IG1, n = 16) and intervention with white chocolate (IG2, n = 15) groups and evaluated before and after 4 weeks of treatment for nutritional status, food consumption, anthropometry, body composition, and laboratory parameters, and quality of life using the instrument of the European Organization for the Research and Treatment of Cancer. Results IG1 progressed with increased screening (p < 0.01) and nutritional (p = 0.04) scores on the Mini Nutritional Assessment tool. Anthropometry and body composition did not change. Regarding antioxidant capacity, reduced glutathione levels increased in IG2 (p = 0.04) and were higher than in IG1 (p < 0.01). Malondealdehyde levels were reduced in IG2 (p = 0.02) at the end of the study. Regarding quality of life, functionality improved in IG1, with a higher score in the functional domain (p = 0.03), and in the role functioning (p < 0.01) and in the social (p < 0.01) subdomains. Conclusions The consumption of chocolate with a greater cocoa content may contribute to the improvement of nutritional status and functionality among older cancer patients in palliative care. The consumption of white chocolate was associated with improved oxidative stress. Trial registration: ClinicalTrials.gov NCT04367493 - April 29, 2020. Retrospectively registered.

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 A Randomised, Cross-Over, Placebo-Controlled Study of Aloe vera in Patients with Irritable Bowel Syndrome: Effects on Patient Quality of Life

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
H. A. Hutchings ◽  
K. Wareham ◽  
J. N. Baxter ◽  
P. Atherton ◽  
J. G. C. Kingham ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Short Form ◽  
Aloe Vera ◽  
Gastrointestinal Symptoms ◽  
Controlled Study ◽  
Double Blind ◽  
Irritable Bowel ◽  
Drop Outs

Background. Irritable bowel syndrome (IBS) is a chronic, difficult to treat condition. The efficacy of Aloe vera in treating IBS symptoms is not yet proven. The purpose of this study was to determine if Aloe vera is effective in improving quality of life. Methods. A multicentre, randomised, double-blind, cross-over placebo controlled study design. Patients were randomised to Aloe vera, wash-out, placebo or placebo, washout, Aloe vera. Each preparation (60 mL) was taken orally twice a day. Patient quality of life was measured using the Gastrointestinal Symptoms Rating Score, Irritable Bowel Syndrome Quality of Life, EuroQol and the Short-Form-12 at baseline and treatment periods 1 and 2. Results. A total of 110 patients were randomised, but only 47 completed all questionnaires and both study arms. Statistical analysis showed no difference between the placebo and Aloe vera treatment in quality of life. Discussion. This study was unable to show that Aloe vera was superior to placebo in improving quality of life. Drop outs and other confounding factors may have impacted on the power of the study to detect a clinically important difference. Conclusion. This study failed to find Aloe vera superior to placebo in improving quality of life proven Irritable Bowel Syndrome patients.

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