Effectiveness of Probiotics to Treat End Stage Renal Disease

August 7, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

Effect of Probiotics on Modulating the Bacterial Translocation and Improving Micro-inflammation in Hemodialysis Patients

Intestinal microbiota has recently emerged as an important player in the progression and complications of chronic kidney disease(CKD). And drug therapy which selects the gut as a target has raised lots of concern. It has been reported that the composition of intestinal flora has changed in uremic patients. Specifically, imbalanced ecosystem has higher number of pathogens such as Clostridia, Enterobacteria,and lower number of beneficial microbes such as Lactobacilli and Bifidobacteria. This modification of intestinal flora can strongly increase transformation of amino acids into Uremic Retention solutes, e.g., indoxyl-sulfate (IS), p-cresyl sulfate (PCS), which are so called gut-derived uremic toxins. The dysbiosis also contributes to an increase in intestinal permeability by disrupting the colonic epithelial tight junction,which may subsequently lead to translocation of endotoxin and bacteria into the host's internal environment,resulting in systemic micro-inflammation.Also all of these can promote the progression of renal failure and the incidence of cardiovascular complications,renal osteodystrophy and anemia.Probiotics is defined by the World Health Organization as 'live microorganisms that, when administered in adequate amounts, confer a health benefit on the host'. Probiotics are being increasingly used for various pathologic conditions.It is said that probiotics have a therapeutic role in maintaining a metabolically balanced gastrointestinal tract (GIT).And in our previous study,the investigators found that in uremic rats,lactobacillus acidophilus can relieve bacterial translocation and decrease the level of inflammatory markers.So our study is mainly designed to investigate whether probiotics can modulate the balance of intestinal ecosystem, prevent the bacterial translocation from gut and alleviate the systemic inflammation in hemodialysis(HD) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a single-centre, double-blind, placebo-controlled, randomised trial. Participants will undergo a 2 week run-in period, followed by randomisation to either probiotics supplements or placebo for 6 months. The study population are hemodialysis patients from Dialysis Department in First Affiliated Hospital of Xi'an Jiaotong University. The Dialysis Department have 400 patients who regularly come to receive dialysis therapy three times a week.It's relatively easy for us to follow up and collect data.Patients who meet the criteria and are able to provide informed consent will be recruited.Then computer-generated randomisation of participants to treatment order will be undertaken by an external statistical consultant. This process of allocation will conceal the randomisation order to researchers and participants. In addition, the supplements will be packed off-site with a generic label.

After randomization,baseline data will be collected and all participants will undergo face-to-face dietary education with a dietitian, incorporating standard hemodialysis education during the first week of run-in.In the week following, and throughout the intervention, patients will be encouraged to maintain stable protein and fibre intakes, with specific attention to maintaining the same sources of these nutrients.Participants' dietary intakes during the study will be assessed every month using a semi-quantitative food frequency questionnaire. And when the trial starts, questionnaires and biological samples will be performed and collected at the corresponding time. All serious adverse events will be reported to the ethics committee, whether deemed to be intervention related or not. Adherence to supplements will be measured by pill count every two weeks.

This study is an explorative clinical trial.And in the absence of any data about the effect of probiotics on hemodialysis patients intestinal and serum microbiota,sample size can't be calculated.Data will be reported as s mean±SD if normally distributed and as median(25-75% percentiles) if not. The Shapiro-Wilk test is performed to assess whether data are normally distributed. Statistical comparisons of normally distributed data are performed using Student's t-test. Mann-Whitney U-test is used to compare the rank variables measuring gastrointestinal symptoms in probiotics and placebo groups. The threshold for statistical significance is at p values <0.05. And an external statistical consultant from our Clinical Research Center will be involved in the data validation and analysis activities.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • maintenance hemodialysis patients(MHP),dialysis age>3 months;
  • signed informed consent.

Exclusion Criteria:

  • intolerance to whole milk and dairy products;
  • patients with kidney transplant, with severe infections, sever heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring artificial feeding;
  • pregnant or nursing women;
  • patients with known gastro-intestinal disease (i.e.,inflammatory bowel disease,crohn's disease,ulcerative colitis),receiving or have received radiation to the bowel or large bowel resection;
  • use of antibiotics, prebiotics or probiotics in the past 4 weeks;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bifid Triple Viable Capsules
BIFICO(Shanghai Sine Pharmaceutical Laboratories Co.Ltd,S10950032), A biological preparation composed of triple viable microbe(Live combined Bifidobacterium, Lactobacillus and enterococcus capsules)
Drug: Bifid Triple Viable Capsules
BIFICO is prescribed as a dose of 4 capsules twice daily in half hours after meals.
Other Names:
  • BIFICO,S10950032
Placebo Comparator: placebo
placebo is also manufactured by Sine Pharmaceutical Laboratories,but only contains starch.And placebo is the same as probiotics in appearance,odor,flavor and color.
Other: placebo
placebo is also prescribed as a dose of 4 capsules twice daily
Other Names:
  • placebo(Shanghai Sine Pharmaceutical Laboratories Co.Ltd)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota
Time Frame: Change from Baseline in faeces bacterial genomic DNA at 6 months
a faeces microbial analysis
Change from Baseline in faeces bacterial genomic DNA at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma detection of bacterial genomic DNA,plasma and fecal metabolomics
Time Frame: Change from Baseline in faeces bacterial genomic DNA at 6 months, fecal and plasma metabolomics at baseline and 6 months
Change from Baseline in faeces bacterial genomic DNA at 6 months, fecal and plasma metabolomics at baseline and 6 months
plasma concentrations of inflammatory biomarkers(hs-C reactive protein,Interleukin(IL)-6,tumor necrosis factor(TNF)-α,endotoxin)
Time Frame: baseline,3 months and 6 months
baseline,3 months and 6 months
Gastrointestinal Symptom Rating Scale (GSRS),SF-36
Time Frame: baseline，3 and 6 months
Monitor Gastrointestinal symptoms and life quality
baseline，3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Hongli Jiang, professor, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

October 7, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRS-2016-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data including baseline characteristics of study population, blood biochemical index and main outcome measures may be made available.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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