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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01391468 |
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Date of registration:
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08/07/2011 |
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Primary sponsor: |
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Public title:
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Beneficial Effect of Probiotics on Chronic Kidney Disease
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Scientific title:
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Beneficial Effect of Probiotics on Chronic Kidney Disease |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01391468 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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I-Kuan Wang |
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Address:
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Telephone:
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886-4-22052121 |
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Email:
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ikwang@seed.net.tw |
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Affiliation:
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Name:
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I-Kuan Wang, MD |
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Address:
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Telephone:
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886-4-22052121 |
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Email:
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ikwang@seed.net.tw |
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Affiliation:
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Name:
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I-Kuan Wang, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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China Medical University Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Intervention(s)
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Dietary Supplement: Cornstarch
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Dietary Supplement: Probiotics
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Primary Outcome(s)
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CVD occurence
[Time Frame: 2 yrs follow-up]
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Secondary Outcome(s)
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occurrence of peritonitis and improvement of GI symptoms
[Time Frame: 2 yrs follow-up]
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Secondary ID(s)
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DMR-99-IRB-308
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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