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

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.

Health-Promoting Role of Lactiplantibacillus plantarum Isolated from Fermented Foods

“…Following these criteria, a substantial body of evidence confirmed the successful use of diverse human probiotic Lpb. plantarum strains as a dietary intervention to prevent and/or ameliorate some widespread diseases, especially acute and chronic GI infections (i.e., C. difficile and H. pylori infections) [ 99 , 175 ], gut inflammatory syndrome (i.e., Irritable Bowel Disease (IBD) and Ulcerative Colitis) [ 176 , 177 ] cardiovascular diseases [ 178 ], hypercholesterolaemia and obesity [ 179 , 180 ], diabetes [ 181 ], gynaecological diseases [ 182 ] as well as colon cancer [ 183 ] and cognitive impairments [ 184 ].…”

A Narrative Review of Gut-Muscle Axis and Sarcopenia: The Potential Role of Gut Microbiota

“… 26 , 27 Kazmierczak-Siedlecka et al found that lactobacillus (extracted from pickle) supplementation could improve exercise performance in a dose-dependent manner and significantly increases muscle mass in healthy people, and reduce the muscle loss in cancer patients. 28 These experiments suggest that lactobacillus may become a biological agent for improving physiological function. 29 …”

“…Supplementing the corresponding microbiota is also beneficial to fight the disease. 28 , 30 Therefore, probiotics are closely related to muscle strength and function and muscle mass. Although there is limited understanding of probiotics’ mechanism on muscle strength and quality benefits at this stage, it is clear that gut microbiota is linked to muscles through endocrine, substance and energy metabolism, immunity and inflammation.…”

Gut Microbiota Modulation in the Context of Immune-Related Aspects of Lactobacillus spp. and Bifidobacterium spp. in Gastrointestinal Cancers

“…L. plantarum 299v, which was originally isolated from human intestine, is characterized by multiple properties [ 35 , 36 , 37 ], e.g., it is able to survive in a wide range of pH, demonstrating a high tolerance to acidic conditions in the stomach and the more basic pHs in duodenum [ 38 ]. L. plantarum 299v also acts against potentially pathogens (e.g., Enterococcus faecalis , Bacillus cereus , Yersinia enterocolitica , Clostridium difficile , and Escherichia coli ) and inhibits their growth in the gut [ 38 ].…”