Probiotics Use in the Chronic Peritoneal Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by National Cheng-Kung University Hospital.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Pro-bio Biotech Co. Ltd.

Information provided by:

National Cheng-Kung University Hospital

ClinicalTrials.gov Identifier:

NCT01076426

First received: February 24, 2010

Last updated: February 25, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2010

Last Updated Date

February 25, 2010

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

peritonitis rate [ Time Frame: one year ] [ Designated as safety issue: No ]
nutrition status [ Time Frame: 3, 6, 9, 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01076426 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Probiotics Use in the Chronic Peritoneal Dialysis Patients

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Peritonitis
Malnutrition

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Probiotics
probiotics treatment

Intervention: Drug: Pro-biotics
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Oligosaccharide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: An-Bang Wu, MD

886-6-2353535 ext 2594

anbang@mail.ncku.edu.tw

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01076426

Other Study ID Numbers ^ICMJE

HR-98-083

Has Data Monitoring Committee

Yes

Responsible Party

An-Bang Wu, MD, National Cheng-Kung University Hospital

Study Sponsor ^ICMJE

National Cheng-Kung University Hospital

Collaborators ^ICMJE

Pro-bio Biotech Co. Ltd.

Investigators ^ICMJE

Principal Investigator:

An-Bang WU, MD

National Cheng-Kung University Hospital

Information Provided By

National Cheng-Kung University Hospital

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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