Phase 4
N=47
Beneficial Effect of Probiotics on Chronic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01391468 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: the Occurrence of Cardiovascular Event and Peritonitis Events — 0; 0; 0; 0 participants — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Probiotics (Dietary_supplement); Cornstarch (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- China Medical University Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Occurrence of Cardiovascular Event and Peritonitis Events |
0; 0; 0; 0 | >0.05 |
| SECONDARY Change of Gastrointestinal Symptoms at 6 Months |
-2.82; -1.38 | 0.744 |
Summary
This is a randomized double blinded placebo control studies are performed in Chronic Kidney Disease (CKD) patients. After informed consent, intervention group receives probiotics containing 109 CFU B. bifidum, B.catenulatum, B. longum, and L.plantarm), while placebo group receives corn starch. In the first year the investigators examine the 60 peritoneal dialysis (PD) patients, in the second year the investigators do the 60 hemodialysis (HD) patients, and in the third year the investigators do the 60 stage 3 and 4 CKD patients. Primary endpoint is cardiovascular event, gastrointestinal symptoms, peritonitis in PD patients, and progression of stage 3 and 4 CKD. Values are compared between the groups by unpaired t test. X2 testis used to compare proportions between the groups. Relative risk and the number needed to treat, both with 95% CI, are used to describe the treatment effect of probiotics. A p value less than 0•05 is regarded as statistically significant.
Eligibility Criteria
Inclusion Criteria
- receiving peritoneal dialysis for more than 3 months, at least 18 years of age, and GFR < 15 ml/min.
- receiving hemodialysis dialysis for more than 3 months, at least 18 years of age, and GFR < 15 ml/min.
- Stage 3 and 4 CKD patients
Exclusion Criteria
- active infectious conditions within the last 30 days,
- pregnancy for female,
- autoimmune disease e.g. SLE.,
- cardiovascular events before.
Data sourced from ClinicalTrials.gov (NCT01391468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.