Beneficial Effect of Probiotics on Chronic Kidney Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by China Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
I-Kuan Wang, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01391468
First received: July 8, 2011
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Dietary Supplement: Probiotics
Dietary Supplement: Cornstarch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Beneficial Effect of Probiotics on Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • CVD occurence [ Time Frame: 2 yrs follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • occurrence of peritonitis and improvement of GI symptoms [ Time Frame: 2 yrs follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Cornstarch
placebo will be given in 6 months
Other Name: Cornstarch
Experimental: Probiotics Dietary Supplement: Probiotics
intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
Other Name: Probiotics

Detailed Description:

Chronic kidney disease (CKD) is a global health issue that has a substantial impact on affected individuals. The prognosis of dialysis patients is poor with 30 to 50 percent 5 year survival in nondiabetic patients and 25 percent in diabetics. Cardiovascular disease accounts for approximately half of death of dialysis patients Chronic inflammation, which is widely seen in long-term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk. Inflammatory markers such as C-reactive protein (CRP),IL-6, Il-18 and TNF-α, are elevated in dialysis and can predict cardiovascular event and all-cause mortality.

Probiotics are microorganisms that have beneficial properties for the host. Three described benefits include suppression of growth or epithelial binding/invasion by pathogenic bacteria, improvement of intestinal barrier function and modulation the immune systems.

Several probiotics preparations induce protective cytokines, including IL-10, and suppress proinflammatory cytokines, such as TNF-α and IL-6. Intestinal microflora is deranged in hemodialysis (HD) patients as an increase in aerobic bacteria such as E. coli and a decrease in anaerobic bacteria such as Bifidobacterium. One study reported that oral administration of ifidobacterium longum in a gastroresistant seamless capsule decreases the the pre-HD serum levels of homocysteine and indoxyl sulfate. Another small-scale study from Japan showed that synbiotics containing lactobacilli and can reduce serum level of p-Cresol in HD patients. High-serum p-cresyl sulfate and indoxyl sulfate levels were associated with renal progression. Serum concentrations of p-cresol are independently associated with overall mortality and cardiovascular disease in HD patients. The aim of the study is 1. to evaluate the difference of intestinal microflora between CKD patients and healthy controls; 2. to evaluate whether the investigators can reduce cardiovascular events in CKD patients, and peritonitis in peritoneal dialysis (PD) patients, retard the progression of stage 3 and 4 CKD patients, and decrease circulating inflammatory markers(CRP, IL-6,IL-18, TNF-α), indoxyl sulfate, p-cresol and homocysteine after probiotics treatment.

Randomized double blinded placebo control studies are performed in 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 PD patients, in the second year the investigators do the 60 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. receiving peritoneal dialysis for more than 3 months, at least 18 years of age, and GFR < 15 ml/min.
  2. receiving hemodialysis dialysis for more than 3 months, at least 18 years of age, and GFR < 15 ml/min.
  3. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391468

Contacts
Contact: I-Kuan Wang, MD 886-4-22052121 ext 2902 ikwang@seed.net.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 413
Contact: I-Kuan Wang    886-4-22052121 ext 2902    ikwang@seed.net.tw   
Principal Investigator: I-kuan Wang, MD         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: I-Kuan Wang, M.D. China Medical University Hospital
  More Information

No publications provided

Responsible Party: I-Kuan Wang, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01391468     History of Changes
Other Study ID Numbers: DMR-99-IRB-308
Study First Received: July 8, 2011
Last Updated: September 18, 2012
Health Authority: Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 27, 2014