Kidney Failure, Chronic Clinical Trial
Official title:
Effect of Probiotics on Modulating the Bacterial Translocation and Improving Micro-inflammation in Hemodialysis Patients
Verified date | August 2018 |
Source | First Affiliated Hospital Xi'an Jiaotong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 30, 2018 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gut microbiota | a faeces microbial analysis | Change from Baseline in faeces bacterial genomic DNA at 6 months | |
Secondary | plasma detection of bacterial genomic DNA,plasma and fecal metabolomics | Change from Baseline in faeces bacterial genomic DNA at 6 months, fecal and plasma metabolomics at baseline and 6 months | ||
Secondary | plasma concentrations of inflammatory biomarkers(hs-C reactive protein,Interleukin(IL)-6,tumor necrosis factor(TNF)-a,endotoxin) | baseline,3 months and 6 months | ||
Secondary | Gastrointestinal Symptom Rating Scale (GSRS),SF-36 | Monitor Gastrointestinal symptoms and life quality | baseline,3 and 6 months |
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