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Status unknownNCT01076426Updated Feb 26, 2010

Probiotics Use in the Chronic Peritoneal Dialysis Patients

A Phase 4 interventional study of Pro-biotics and Oligosaccharide in Peritonitis and Malnutrition, sponsored by National Cheng-Kung University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-02-26.

Sponsored by National Cheng-Kung University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peritonitis
  • Malnutrition

Keywords

  • probiotic
  • peritoneal dialysis
  • peritonitis
  • nutrition status
03

In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's planned enrollment of 100 is close to the median of 95 across 118 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. uremia patient under chronic peritoneal dialysis ≧ 3 months
    1. Age between 16 and 75 years

Exclusion criteria

Exclusion Criteria:

    1. uremia patient with advanced malignance disease
    1. uremia patient had more than 2 episode of G(+) peritonitis within the last one year
    1. uremia patient with expected life ≦ 1 years
    1. uremia patient with the history of drug or alcohol abuse
    1. uremia patient with poor drug compliance
    1. uremia patient with active infection disease
    1. uremia patient with uncontrolled autoimmune disease such as SLE
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Probiotics

    probiotics treatment

    Drug: Pro-biotics

  • Placebo comparator
    Placebo

    Dietary Supplement: Oligosaccharide

Interventions

  • DrugPro-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 supplementOligosaccharide

    oligosaccharide one pack per day

06

What researchers measure

Primary outcomes

  1. peritonitis rate

    Time frame: one year

  2. nutrition status

    Time frame: 3, 6, 9, 12 months

07

Study locations

1 of 1 sites recruiting
  • National Cheng Kung University Hospital
    Tainan, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01076426
Lead sponsor
National Cheng-Kung University Hospital
Collaborators
Pro-bio Biotech Co. Ltd.
First posted
Feb 26, 2010
Start date
Feb 2010
Primary completion
Mar 2010 (estimated)
Completion
Mar 2011 (estimated)
Last update
Feb 26, 2010

Study contacts

An-Bang Wu, MD
Contact
anbang@mail.ncku.edu.tw
886-6-2353535 ext. 2594
An-Bang WU, MD
principal investigator · National Cheng-Kung University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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