A Phase 2/3 interventional study of probiotics and Placebo in Kidney Failure, Chronic, sponsored by China Agricultural University. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by China Agricultural University · Phase 2/3, Interventional, and Prevention
The purpose of this study is to investigate the effects of oral administration of probiotics on the metabolism of uremic toxins, in the patients with End Stage Renal Disease (ESRD). One hundred and fifty hemodialysis patients are recruited, and a Double Blind Randomized Parallel Controlled Trial was performed.The microbiota-derived uremic toxin, such as indoxyl sulfate and p-cresol sulfate, are measured as Primary Outcome. The Fecal microbiome, fecal metabolites, blood metabolites, defecation, Gastrointestinal Symptoms The Kidney Disease Quality of Life and The Occurrence of Cardiovascular Event are also assessed.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 150 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →China Agricultural University is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patient take two chewing tablet per day, which contain 4.0E+10 CFU of probiotics.
Dietary Supplement: probiotics
The patient take two placebo chewing tablet per day.
Dietary Supplement: Placebo
Daily take 4.0E+10 CFU of probiotics
Changes in Microbiota-derived uremic toxin
follow up the patients at Month 0, 3, 6
Time frame: 6 months
Changes in Fecal Microbiome
follow up the patients at Month 0, 3, 6
Time frame: 6 months
Changes in Fecal metabolites
follow up the patients at Month 0, 3, 6
Time frame: 6 months
Changes in Blood metabolites
follow up the patients at Month 0, 3, 6
Time frame: 6 months
Defecation questionnaire
follow up the patients at Month 0, 3, 6
Time frame: 6 months
Gastrointestinal Symptoms
follow up the patients at Month 0, 3, 6
Time frame: 6 months
The Kidney Disease Quality of Life
follow up the patients at Month 0, 3, 6
Time frame: 6 months
The Occurrence of Cardiovascular Event
Time frame: 6 month follow-up
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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China Agricultural University