Probiotics Use in the Chronic Peritoneal Dialysis Patients

Phase 4

• Conditions: Peritonitis; Malnutrition
• Interventions: Drug: Pro-biotics; Dietary Supplement: Oligosaccharide

• Registration Number: NCT01076426
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-25
• Last Update Submitted: 2010-02-25
• Study First Posted: 2010-02-26
• Last Update Posted: 2010-02-26
• Primary Completion: 2010-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotics	Pro-biotics	probiotics treatment
Placebo	Oligosaccharide	-

Primary Outcome Measures

Name	Time	Method
peritonitis rate	one year
nutrition status	3, 6, 9, 12 months

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan