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