Probiotics Use in the Chronic Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01076426
Recruitment Status : Unknown
Verified February 2010 by National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Pro-bio Biotech Co. Ltd.
Information provided by:
National Cheng-Kung University Hospital

February 24, 2010
February 26, 2010
February 26, 2010
February 2010
March 2010   (Final data collection date for primary outcome measure)
  • peritonitis rate [ Time Frame: one year ]
  • nutrition status [ Time Frame: 3, 6, 9, 12 months ]
Same as current
No Changes Posted
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Probiotics Use in the Chronic Peritoneal Dialysis Patients
The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis
The purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.
Peritoneal dialysis was one of therapies for uremia patient. However, peritoneal dialysis related peritonitis was a major complication for these patients. Severe and prolong peritonitis may led to membrane failure and drop out of peritoneal dialysis. Among the pathogens, G(+) bacteria came from skin surface and G(-) bacteria came from gastrointestinal tract. The later might be related to the pathogens in the gastrointestinal tract, and led to peritonitis if constipation or diarrhea developed. In addition, intestinal pathogens may be related to chronic inflammation in uremia patients. There was a MIA syndrome (malnutrition, inflammation and atherosclerosis) noted before, and chronic inflammation may be related to malnutrition. Today, we know that nutrition status and inflammation marker (CRP) may be associated with patients' outcome. Many gastrointestinal syndromes such as constipation suffer our patients. The dialysate in the abdominal cavity may further exacerbate the appetite. The probiotics was though to improve the pathogens in intestinal tract, improve gastrointestinal function. We want to decrease the incidence of peritonitis by using the probiotics. In addition, the improvement in gastrointestinal function can increase the nutrition status.
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Peritonitis
  • Malnutrition
  • Drug: Pro-biotics
    Pro-biotics and placebo one pack per day is given to the two group. And then evaluate the peritonitis rate and nutrition status.
  • Dietary Supplement: Oligosaccharide
    oligosaccharide one pack per day
  • Experimental: Probiotics
    probiotics treatment
    Intervention: Drug: Pro-biotics
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Oligosaccharide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
March 2011
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1. uremia patient under chronic peritoneal dialysis ≧ 3 months
  • 2. Age between 16 and 75 years

Exclusion Criteria:

  • 1. uremia patient with advanced malignance disease
  • 2. uremia patient had more than 2 episode of G(+) peritonitis within the last one year
  • 3. uremia patient with expected life ≦ 1 years
  • 4. uremia patient with the history of drug or alcohol abuse
  • 5. uremia patient with poor drug compliance
  • 6. uremia patient with active infection disease
  • 7. uremia patient with uncontrolled autoimmune disease such as SLE
Sexes Eligible for Study: All
16 Years to 75 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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An-Bang Wu, MD, National Cheng-Kung University Hospital
National Cheng-Kung University Hospital
Pro-bio Biotech Co. Ltd.
Principal Investigator: An-Bang WU, MD National Cheng-Kung University Hospital
National Cheng-Kung University Hospital
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP