Evaluation Of The Efficacy of a Strain-Specific Probiotic Formulation in Hemodialysis Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Previous studies found that lactic acid bacteria could inhibit the activity of the
      performance of aristolochic acids (AAs) and improve apoptosis of proximal tubular epithelial
      cells (NRK-52E) and renal fibrosis on rats. The aim of this study is to assessment a novel
      health food of lactic acid bacteria for preventing renal dysfunction and replacing or
      assisting conventional drug treatment. This study in 300 hemodialysis patients with dialysis
      quality assessment index (KT/V, urea reduction ratio (URR), albumin, prealbumin, Hb, CRP…)
      screened for more than three months, and the stability of the situation in dialysis patients.
      They will be divided into two groups in order to conduct ergonomic assessments. One group
      maintains their original diet and medicine. The other group will take the novel lactic acid
      bacteria and placebo (1x1011 cfu/3±0.2 g/bag) in every morning and evening after their meals.
      The effect of 0, 6, 12, 18, 24 weeks of the novel lactic acid bacteria will be assessed after
      starvation for 4 weeks. Group C was the control group did not give any test samples, but
      continued to observe. The overall goal of the aforementioned study is to develop a novel food
      product of lactic acid bacteria which can improve dialysis quality for hemodialysis patients.
      The investigators hope that this novel product can get a patent and be commercialized.
    

Detailed description: 
      Background:

      Insulin resistance (IR) and its associated metabolic disorders are common features of chronic
      kidney disease (CKD)and accumulating evidence suggested they are important contributors for
      the cardiovascular burden of CKD patients. In recent years, the modification of the
      intestinal ﬂora and activation of inflammation pathways have been implicated in the
      pathogenesis of IR in patients suffering from metabolic syndrome. These important discoveries
      have led to major advances in understanding the mechanisms of uraemia-induced IR.
      Furthermore, recent studies show impairment of the intestinal barrier and renal function
      function as well as changes in the composition of the gut microbiome can contribute to the
      prevailing inflammation, and gut-derived uremic toxins. Some of these uraemic toxins have
      been linked to the pathogenesis of IR.

      Probiotics is one of the functional foods believed to mediate their health promoting
      activities through modulating the composition of the gut health. Ingestion of probiotics has
      been shown not only to influence gut microbiota composition but also the secretion of the gut
      hormones that ameliorate insulin resistance in animal models. Limited trials in human also
      showed that supplementation with probiotic not only affect glucose homeostasis, but improved
      other diabetes related comorbidities such as metabolic syndrome, hypertension, and
      hyperlipidemia. It also increasing clear that many of the multifactorial physiological
      functions of gut bacteria are highly strain specific, preselection of appropriate probiotic
      strains based on their expression of functional biomarkers is critical

      Objectives and hypotheses:

      To address this research gap, this randomized controlled trial is proposed to determine the
      efficacy of probiotic formulation to improve metabolic profile and reduction of uremic toxins
      through modulating gut microbiota composition and gut immune function in hemodialysis
      patients.The investigators hypothesized that the probiotic supplementations will improve
      blood glucose control as well as other related metabolic aberrations and lower the levels of
      gut-derived uremic toxins.

      Methodology:

      This is a single center, double blind randomized parallel group control trial with 6 months
      probiotic formulation with strain specific lactobacillus or placebo. After screening the
      eligible subjects will be selected. Then, after consent taking and 4 weeks of washout period,
      participants will be randomly assigned to either receive probiotic formulation or placebo for
      6 months. Measurements of blood parameters including glycemic control related parameters,
      lipid profile, nutritional markers, inflammatory markers and uremic toxins. Nutritional
      assessments, quality of life assessment and anthropometry measurements will take place at
      baseline, and after 24 months.
    

Intervention name(s): Probiotic packet; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic formulation will be given at a dose of one packet thrice daily for 24 weeks, amounting to a total of 300 billion colony forming units(CFU)/day. Each packet contains 100 billion viable lyophilized bacteria of three strains of Lactobacillus viz Lactococcus lactis subsp. Lactis LL358 (BCRC910699)、Lactobacillus salivarius LS159 (BCRC910700) and Lactobacillus pentosus and excipients.; Placebo packet will be given at a dose of one sachet thrice daily for 24 weeks; Placebo packet contain all excipients as present in packets (without the 3 strains of bacteria as mentioned above).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lactic acid bacteria; dyslipidemia uremic toxins; Hemodialysis