Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland.
Department of Clinical Nutrition and Dietetics, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.
Nutr J. 2020 Sep 11;19(1):98. doi: 10.1186/s12937-020-00598-w.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03940768 .
营养治疗是多学科抗癌治疗中最重要的组成部分之一。家庭肠内营养被认为是一种安全的治疗方法，但它可能会引起副作用，如恶心、呕吐、腹痛和腹泻。目前尚不确定腹泻是肠内配方的结果还是肠道菌群失调的结果。改变肠道微生物群组成的方法之一是使用益生菌菌株。已发现摄入植物乳杆菌 299v 可减少肠易激综合征和艰难梭菌感染的不良反应——这些疾病与肠内营养的副作用具有相同的症状。因此，本研究的主要目的是确定植物乳杆菌 299v 对预防接受家庭肠内营养的癌症患者体重减轻的影响。次要目的是评估该益生菌菌株在改善营养状况、肠内营养耐受性和患者生活质量方面的作用。
将招募 40 名接受家庭肠内营养的癌症患者参加这项临床试验，并将他们随机分为两组，每天服用两次植物乳杆菌 299v（Sanprobi IBS®）胶囊或安慰剂，持续 12 周，采用双盲法。将进行实验室检查（白蛋白、总蛋白、转铁蛋白和总淋巴细胞计数水平）、人体测量参数（体重、体脂肪含量、肌肉质量和总身体水分）、营养风险筛查（NRS 2002）、肠内营养耐受性以及生活质量评估。在基线和治疗 4 周和 12 周后进行测量。
在给予肠内营养期间观察到的不良反应对肠内配方的耐受性产生负面影响，进而影响患者的生活质量。以前的研究表明，益生菌可能会减轻与肠内营养相关的胃肠道症状。因此，给予植物乳杆菌 299v 可能有助于改善接受家庭肠内营养的癌症患者的营养状况、肠内营养耐受性和生活质量。
ClinicalTrials.gov 标识符：NCT03940768。
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