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Probiotics Use in the Chronic Peritoneal Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pro-bio Biotech Co. Ltd.
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01076426
First received: February 24, 2010
Last updated: February 25, 2010
Last verified: February 2010

February 24, 2010
February 25, 2010
February 2010
March 2010   (final data collection date for primary outcome measure)
  • peritonitis rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  • nutrition status [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076426 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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
Both
16 Years to 75 Years
No
Contact: An-Bang Wu, MD 886-6-2353535 ext 2594 anbang@mail.ncku.edu.tw
Taiwan
 
NCT01076426
HR-98-083
Yes
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