Evaluation of the Effects of a Probiotic Formulation in Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change from Baseline Triglyceride/HDL cholesterol ratio at 3 months, 6 months and 3 months after the trial
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both sexes aged between 20-75 years.
- •Received stable hemodialysis at least 3 months.
- •Written informed consent.
Exclusion Criteria
- •patients with severe infections, severe heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring oral nutrition supplements;
- •Inability to follow protocol.
- •patients with known gastro-intestinal disease (i.e.,inflammatory bowel disease,crohn's disease,ulcerative colitis)
- •Use of antibiotics, prebiotics or probiotics and immunosuppression medications in the past 4 weeks
- •Pregnancy or wishing/trying to get pregnant
Outcomes
Primary Outcomes
Change from Baseline Triglyceride/HDL cholesterol ratio at 3 months, 6 months and 3 months after the trial
Time Frame: baseline,3 months, 6 months and 3 months after the trial
Plasma triglycerides are measured by enzymatic methods. High-density lipoprotein (HDL) cholesterol is measured in the supernatant after sodium phosphotungstate/magnesium chloride precipitation.
Secondary Outcomes
- Gut function questionnaire as a measure of tolerability(Symptoms during first month)
- plasma concentrations of microbial translocation biomarkers(baseline,3 months, 6 months and 3 months after the trial)
- Nutritional Status(baseline and 6 months)
- Quality of life(baseline and 6 months)
- Plasma concentrations of typical gut-derived uremic toxins(Indoxyl sulfate and p-cresyl sulfate)(baseline,3 months, 6 months and 3 months after the trial)
- plasma concentrations of inflammatory biomarkers(baseline,3 months, 6 months and 3 months after the trial)
Investigators
Paik Seong Lim
National Science Council
Tungs' Taichung Metroharbour Hospital