Probiotics Use in the Chronic Peritoneal Dialysis Patients

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01076426
• Other study ID #: HR-98-083
• Status: Recruiting
• Phase: Phase 4
• First received: February 24, 2010
• Last updated: February 25, 2010
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: National Cheng-Kung University Hospital
• Contact: An-Bang Wu, MD
• Phone: 886-6-2353535
• Email: anbang[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition
• Peritonitis

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	Pro-bio Biotech Co. Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peritonitis rate		one year	No
Primary	nutrition status		3, 6, 9, 12 months	No