CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 50 enrolled
Drug / intervention
Bifid Triple Viable Capsules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02929225
NCT02929225Early Ph 1Completed

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

First Affiliated Hospital Xi'an Jiaotong University·interventional·Posted Oct 11, 2016·Updated Aug 8, 2018

In Brief

A Early Phase 1 clinical trial evaluating Bifid Triple Viable Capsules and placebo for Kidney Failure, Chronic. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 11, 2016
Enrollment StartDec 1, 2016
Primary CompletionJan 30, 2018
Study CompletionMar 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.7 years ago

Interventions

Bifid Triple Viable Capsulesdrug

BIFICO is prescribed as a dose of 4 capsules twice daily in half hours after meals.

placeboother

placebo is also prescribed as a dose of 4 capsules twice daily