| Trial ID: | L0402 |
| Source ID: | NCT02929225
|
| Associated Drug: |
Bifid Triple Viable Capsules
|
| Title: |
Effectiveness of Probiotics to Treat End Stage Renal Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic
|
| Interventions: |
DRUG: Bifid Triple Viable Capsules|OTHER: placebo
|
| Outcome Measures: |
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|plasma concentrations of inflammatory biomarkers(hs-C reactive protein,Interleukin(IL)-6,tumor necrosis factor(TNF)-α,endotoxin), baseline,3 months and 6 months|Gastrointestinal Symptom Rating Scale (GSRS),SF-36, Monitor Gastrointestinal symptoms and life quality, baseline，3 and 6 months
|
| Sponsor/Collaborators: |
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-12
|
| Completion Date: |
2018-03-30
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-08
|
| Locations: |
First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02929225
|
