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Probiotics Use in the Chronic Peritoneal Dialysis Patients

NCT ID: NCT01076426

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-03-31

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.

Conditions

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Peritonitis Malnutrition

Keywords

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probiotic peritoneal dialysis peritonitis nutrition status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotics

probiotics treatment

Group Type EXPERIMENTAL

Pro-biotics

Intervention Type DRUG

Pro-biotics and placebo one pack per day is given to the two group. And then evaluate the peritonitis rate and nutrition status.

Placebo

Group Type PLACEBO_COMPARATOR

Oligosaccharide

Intervention Type DIETARY_SUPPLEMENT

oligosaccharide one pack per day

Interventions

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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.

Intervention Type DRUG

Oligosaccharide

oligosaccharide one pack per day

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pro-bio Biotech Co. Ltd.

INDUSTRY

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Cheng-Kung University Hospital

Principal Investigators

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An-Bang WU, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

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National Cheng Kung University Hospital

Tainan City, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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An-Bang Wu, MD

Role: CONTACT

Phone: 886-6-2353535

Email: [email protected]

Other Identifiers

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HR-98-083

Identifier Type: -

Identifier Source: org_study_id