search
Back to results

Probiotics Use in the Chronic Peritoneal Dialysis Patients

Primary Purpose

Peritonitis, Malnutrition

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Pro-biotics
Oligosaccharide
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritonitis focused on measuring probiotic, peritoneal dialysis, peritonitis, nutrition status

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

probiotics treatment

Outcomes

Primary Outcome Measures

peritonitis rate
nutrition status

Secondary Outcome Measures

Full Information

First Posted
February 24, 2010
Last Updated
February 25, 2010
Sponsor
National Cheng-Kung University Hospital
Collaborators
Pro-bio Biotech Co. Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT01076426
Brief Title
Probiotics Use in the Chronic Peritoneal Dialysis Patients
Official Title
The Clinical Use of Probiotics in the Uremia Patients Under Chronic Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
Pro-bio Biotech Co. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Malnutrition
Keywords
probiotic, peritoneal dialysis, peritonitis, nutrition status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
probiotics treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pro-biotics
Intervention Description
Pro-biotics and placebo one pack per day is given to the two group. And then evaluate the peritonitis rate and nutrition status.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligosaccharide
Intervention Description
oligosaccharide one pack per day
Primary Outcome Measure Information:
Title
peritonitis rate
Time Frame
one year
Title
nutrition status
Time Frame
3, 6, 9, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
An-Bang Wu, MD
Phone
886-6-2353535
Ext
2594
Email
anbang@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An-Bang WU, MD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Probiotics Use in the Chronic Peritoneal Dialysis Patients

We'll reach out to this number within 24 hrs