Completed

Probiotics Impact on Bacterial Translocation and Micro-inflammation in Hemodialysis Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This early phase 1 study aims to evaluate how probiotics affect the gut microbiota in hemodialysis patients, by analyzing the microbial content in faeces.

What is being tested

Bifid Triple Viable Capsules

+ placebo

DrugOther
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 70 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: December 2016
See protocol details

Summary

Principal SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2016

Actual date on which the first participant was enrolled.

This study explores the effects of probiotics on hemodialysis patients. It aims to understand how probiotics can modify the bacterial translocation and improve micro-inflammation in these patients. The study is important as it targets a specific population - patients undergoing hemodialysis at the Dialysis Department in the First Affiliated Hospital of Xi'an Jiaotong University. The potential outcomes of this study could lead to improved care and treatment strategies for hemodialysis patients, addressing current challenges in managing their condition. Participants in this study will first go through a 2-week run-in period, after which they will be randomly assigned to receive either probiotics supplements or a placebo for 6 months. All participants will receive face-to-face dietary education from a dietitian and will be encouraged to maintain stable protein and fibre intakes throughout the intervention. The study's results will be measured through a faeces microbial analysis, which will evaluate changes in the gut microbiota. Participants' dietary intakes will be assessed monthly using a semi-quantitative food frequency questionnaire. Adherence to supplements will be monitored by pill count every two weeks. All serious adverse events will be reported to the ethics committee, regardless of whether they are related to the intervention or not.

Official TitleEffect of Probiotics on Modulating the Bacterial Translocation and Improving Micro-inflammation in Hemodialysis Patients
NCT02929225
Principal SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

2 inclusion criteria required to participate
maintenance hemodialysis patients(MHP),dialysis age>3 months;

signed informed consent.

5 exclusion criteria prevent from participating
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;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
BIFICO(Shanghai Sine Pharmaceutical Laboratories Co.Ltd,S10950032), A biological preparation composed of triple viable microbe(Live combined Bifidobacterium, Lactobacillus and enterococcus capsules)

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, ChinaOpen First Affiliated Hospital of Xi'an Jiaotong University in Google Maps
CompletedOne Study Center