Probiotics Impact on Bacterial Translocation and Micro-inflammation in Hemodialysis Patients
This early phase 1 study aims to evaluate how probiotics affect the gut microbiota in hemodialysis patients, by analyzing the microbial content in faeces.
Bifid Triple Viable Capsules
+ placebo
Urogenital Diseases+10
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, ChinaOpen First Affiliated Hospital of Xi'an Jiaotong University in Google Maps