Evaluation Of The Efficacy of a Strain-Specific Probiotic Formulation in Hemodialysis Patients

NCT03066921 | Completed DMC

• 1 other identifier: 104012
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Lactic acid bacteria; dyslipidemia uremic toxins; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Triglyceride/HDL cholesterol ratio at 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.

  baseline,3 months, 6 months and 3 months after the trial

Secondary Outcomes (6)

• 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

• plasma concentrations of microbial translocation biomarkers

  baseline,3 months, 6 months and 3 months after the trial

• Quality of life

  baseline and 6 months

• Nutritional Status

  baseline and 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: Placebo

Probiotic packet

EXPERIMENTAL

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.

Dietary Supplement: Probiotic packet

Interventions

Probiotic packet DIETARY_SUPPLEMENT

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.

Probiotic packet

Placebo DIETARY_SUPPLEMENT

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).

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes aged between 20-75 years.
• Received stable hemodialysis at least 3 months.
• Written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Paik Seong Lim: lead

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

Related Publications (1)

• Lim PS, Wang HF, Lee MC, Chiu LS, Wu MY, Chang WC, Wu TK. The Efficacy of Lactobacillus-Containing Probiotic Supplementation in Hemodialysis Patients: A Randomized, Double-Blind, Placebo-Controlled Trial. J Ren Nutr. 2021 Mar;31(2):189-198. doi: 10.1053/j.jrn.2020.07.002. Epub 2020 Sep 6.

  PMID: 32900583 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paik Seong Lim, PhD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Science Council

Model Details: Randomized placebo controlled trial

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 1, 2017
• Study Start: June 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)