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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
History of Changes
  Purpose

The purpose of this study is to determine whether probiotics can improve the nutrition status and prevent peritonitis in the chronic peritoneal dialysis patients.


Condition Intervention Phase
Peritonitis
Malnutrition
 Drug: Pro-biotics
Dietary Supplement: Oligosaccharide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
probiotics treatment
 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.
Placebo Comparator: Placebo Dietary Supplement: Oligosaccharide
oligosaccharide one pack per day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076426

Contacts
Contact: An-Bang Wu, MD 886-6-2353535 ext 2594 anbang@mail.ncku.edu.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Sponsors and Collaborators
National Cheng-Kung University Hospital
Pro-bio Biotech Co. Ltd.
Investigators
Principal Investigator: An-Bang WU, MD National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: An-Bang Wu, MD, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01076426     History of Changes
Other Study ID Numbers: HR-98-083
Study First Received: February 24, 2010
Last Updated: February 25, 2010
Health Authority: Taiwan: National Bureau of Controlled Drugs

Keywords provided by National Cheng-Kung University Hospital:
probiotic
peritoneal dialysis
peritonitis
nutrition status

Additional relevant MeSH terms:
Peritonitis
Malnutrition
Peritoneal Diseases
Digestive System Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013