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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

Brief Summary:
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 or disease Intervention/treatment Phase
Peritonitis Malnutrition Drug: Pro-biotics Dietary Supplement: Oligosaccharide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis
Study Start Date : February 2010
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. peritonitis rate [ Time Frame: one year ]
  2. nutrition status [ Time Frame: 3, 6, 9, 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01076426

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Contact: An-Bang Wu, MD 886-6-2353535 ext 2594

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National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Sponsors and Collaborators
National Cheng-Kung University Hospital
Pro-bio Biotech Co. Ltd.
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Principal Investigator: An-Bang WU, MD National Cheng-Kung University Hospital
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Responsible Party: An-Bang Wu, MD, National Cheng-Kung University Hospital Identifier: NCT01076426    
Other Study ID Numbers: HR-98-083
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: February 26, 2010
Last Verified: February 2010
Keywords provided by National Cheng-Kung University Hospital:
peritoneal dialysis
nutrition status
Additional relevant MeSH terms:
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Nutrition Disorders
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases