Probiotics Use in the Chronic Peritoneal Dialysis Patients

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

Detailed Description
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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.

Official Title
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The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis

Conditions
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Peritonitis, Malnutrition

Intervention / Treatment
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* Drug: Pro-biotics
* Dietary Supplement: Oligosaccharide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>probiotics treatment | Drug: Pro-biotics<br>* Pro-biotics and placebo one pack per day is given to the two group. And then evaluate the peritonitis rate and nutrition status.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Oligosaccharide<br>* oligosaccharide one pack per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peritonitis rate |  | one year | 
| nutrition status |  | 3, 6, 9, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, peritoneal dialysis, peritonitis, nutrition status