Probiotics Use in the Chronic Peritoneal Dialysis Patients

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01076426

Enrollment

100

Registered

2010-02-26

Start date

2010-02-28

Completion date

2011-03-31

Last updated

2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Peritonitis

Keywords

probiotic, peritoneal dialysis, peritonitis, nutrition status

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
peritonitis rate	one year
nutrition status	3, 6, 9, 12 months

Countries

Taiwan

Contacts

Primary ContactAn-Bang Wu, MD

anbang@mail.ncku.edu.tw886-6-2353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026